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U.S. Department of Health and Human Services

Class 2 Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)

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  Class 2 Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS) see related information
Date Initiated by Firm January 11, 2018
Date Posted January 25, 2018
Recall Status1 Terminated 3 on July 07, 2021
Recall Number Z-0487-2018
Recall Event ID 78918
510(K)Number K162012  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2


The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
Code Information Model, Catalogue, or Code/ UDI/ Mfg. Lot or Serial Number Model, Catalogue or Code # UDI # Mfg. Lot or Serial # 2092670-001-510157 00840682109666SKN16290004SA SKN16290004SA 2092670-001-510854 00840682109666SKN17090034SA SKN17090034SA 2092670-001-510854 00840682109666SKN17270013SA SKN17270013SA 2092670-001-510854 00840682109666SKN17270014SA SKN17270014SA 2092670-001-516138 00840682109666SKN16440004SA SKN16440004SA 2092670-001-516138 00840682109666SKN16440005SA SKN16440005SA 2092670-001-516138 00840682109666SKN17130042SA SKN17130042SA 2092670-001-516138 00840682109666SKN17130076SA SKN17130076SA 2092670-001-516138 00840682109666SKN17130082SA SKN17130082SA 2092670-001-516138 00840682109666SKN16440003SA SKN16440003SA 2092670-001-516138 00840682109666SKN17200095SA SKN17200095SA 2092670-001-516138 00840682109666SKN17210183SA SKN17210183SA 2092670-001-516138 00840682109666SKN17210184SA SKN17210184SA 2092670-001-516138 00840682109666SKN17300018SA SKN17300018SA 2092670-001-516138 00840682109666SKN17350035SA SKN17350035SA 2092670-001-516138 00840682109666SKN17350036SA SKN17350036SA 2092670-001-516138 00840682109666SKN17390030SA SKN17390030SA 2092670-001-516138 00840682109666SKN17390031SA SKN17390031SA 2092670-001-516138 00840682109666SKN17400032SA SKN17400032SA 2092670-001-516138 00840682109666SKN17400033SA SKN17400033SA 2092670-001-516138 00840682109666SKN17400034SA SKN17400034SA 2092670-001-516138 00840682109666SKN17400035SA SKN17400035SA 2092670-001-516138 00840682109666SKN17400036SA SKN17400036SA 2092670-001-516138 00840682109666SKN17400037SA SKN17400037SA 2092670-001-516138 00840682109666SKN17400038SA SKN17400038SA 2092670-001-516138 00840682109666SKN17400039SA SKN17400039SA 2092670-001-516138 00840682109666SKN17410001SA SKN17410001SA 2092670-001-516138 00840682109666SKN17410002SA SKN17410002SA 2092670-001-516138 00840682109666SKN17410003SA SKN17410003SA 2092670-001-516138 00840682109666SKN17410007SA SKN17410007SA 2092670-001-516138 00840682109666SKN17410008SA SKN17410008SA 2092670-001-516138 00840682109666SKN17410012SA SKN17410012SA 2092670-001-516138 00840682109666SKN17410014SA SKN17410014SA 2092670-001-516138 00840682109666SKN17410030SA SKN17410030SA 2092670-001-517537 00840682109666SKN17310001SA SKN17310001SA 2092670-001-517537 00840682109666SKN17310002SA SKN17310002SA 2092670-001-517537 00840682109666SKN17310003SA SKN17310003SA 2092670-001-517537 00840682109666SKN17310008SA SKN17310008SA 2092670-001-517537 00840682109666SKN17310012SA SKN17310012SA 2092670-001-517537 00840682109666SKN17310053SA SKN17310053SA 2092670-001-517537 00840682109666SKN17330022SA SKN17330022SA 2092670-001-517537 00840682109666SKN17360037SA SKN17360037SA 2092670-001-517537 00840682109666SKN17360038SA SKN17360038SA 2092670-001-517537 00840682109666SKN17380077SA SKN17380077SA 2092670-001-517537 00840682109666SKN17380078SA SKN17380078SA 2092670-001-517537 00840682109666SKN17500040SA SKN17500040SA 2092670-001-517537 00840682109666SKN17500046SA SKN17500046SA 2092670-001-517537 00840682109666SKN17500047SA SKN17500047SA 2092670-001-517537 00840682109666SKN17500048SA SKN17500048SA 2092670-001-517537 00840682109666SKN17500049SA SKN17500049SA 2092670-001-517537 00840682109666SKN17510033SA SKN17510033SA 2092670-001-517538 00840682109666SKN17480003SA SKN17480003SA 2092670-001-517538 00840682109666SKN17480004SA SKN17480004SA 2092670-001-517614 00840682109666SKN17320031SA SKN17320031SA 2092670-001-517614 00840682109666SKN17380003SA SKN17380003SA 2092670-001-517614 00840682109666SKN17420052SA SKN17420052SA 2092670-001-517614 00840682109666SKN17450040SA SKN17450040SA 2092670-001-517614 00840682109666SKN17450049SA SKN17450049SA 2092670-001-517614 00840682109666SKN17450050SA SKN17450050SA 2092670-001-517616 00840682109666SKN17430038SA SKN17430038SA 2092670-001-517616 00840682109666SKN17430040SA SKN17430040SA 2092670-001-517616 00840682109666SKN17430041SA SKN17430041SA 2092670-001-517617 00840682109666SKN17350027SA SKN17350027SA 2092670-001-517617 00840682109666SKN17400028SA SKN17400028SA 2092670-001-517617 00840682109666SKN17430002SA SKN17430002SA 2092670-001-517617 00840682109666SKN17430006SA SKN17430006SA 2092670-001-517617 00840682109666SKN17430054SA SKN17430054SA 2092670-001-517617 00840682109666SKN17440069SA SKN17440069SA 2092670-001-517617 00840682109666SKN17460032SA SKN17460032SA 2092670-001-517617 00840682109666SKN17460044SA SKN17460044SA 2092670-001-517764 00840682109666SKN17390032SA SKN17390032SA 2092670-001-517764 00840682109666SKN17390033SA SKN17390033SA 2092670-001-517764 00840682109666SKN17390034SA SKN17390034SA 2092670-001-517764 00840682109666SKN17420093SA SKN17420093SA 2092670-001-517764 00840682109666SKN17420094SA SKN17420094SA 2092670-001-517764 00840682109666SKN17420095SA SKN17420095SA 2092670-001-517764 00840682109666SKN17430020SA SKN17430020SA 2092670-001-517764 00840682109666SKN17440061SA SKN17440061SA 2092670-001-517764 00840682109666SKN17440062SA SKN17440062SA 2092670-001-517769 00840682109666SKN17330044SA SKN17330044SA 2092670-001-517769 00840682109666SKN17330053SA SKN17330053SA 2092670-001-517769 00840682109666SKN17370079SA SKN17370079SA 2092670-001-517769 00840682109666SKN17370080SA SKN17370080SA 2092670-001-517769 00840682109666SKN17380026SA SKN17380026SA 2092670-001-517769 00840682109666SKN17390035SA SKN17390035SA 2092670-001-517769 00840682109666SKN17390036SA SKN17390036SA 2092670-001-517769 00840682109666SKN17390037SA SKN17390037SA 2092670-001-517769 00840682109666SKN17390064SA SKN17390064SA 2092670-001-517769 00840682109666SKN17390065SA SKN17390065SA 2092670-001-517769 00840682109666SKN17400013SA SKN17400013SA 2092670-001-517769 00840682109666SKN17420064SA SKN17420064SA 2092670-001-517769 00840682109666SKN17420065SA SKN17420065SA 2092670-001-517769 00840682109666SKN17420103SA SKN17420103SA 2092670-001-517769 00840682109666SKN17420106SA SKN17420106SA 2092670-001-517769 00840682109666SKN17430033SA SKN17430033SA 2092670-001-517769 00840682109666SKN17450003SA SKN17450003SA 2092670-001-517769 00840682109666SKN17450016SA SKN17450016SA 2092670-001-517769 00840682109666SKN17460029SA SKN17460029SA 2092670-001-517897 00840682109666SKN17450037SA SKN17450037SA 2092670-001-518979 00840682109666SKN17300011SA SKN17300011SA 2092670-001-518979 00840682109666SKN17330004SA SKN17330004SA 2092670-001-518979 00840682109666SKN17360041SA SKN17360041SA 2092670-001-518979 00840682109666SKN17360042SA SKN17360042SA 2092670-001-518979 00840682109666SKN17360043SA SKN17360043SA 2092670-001-518979 00840682109666SKN17360044SA SKN17360044SA 2092670-001-518979 00840682109666SKN17360045SA SKN17360045SA 2092670-001-518979 00840682109666SKN17360046SA SKN17360046SA 2092670-001-518979 00840682109666SKN17360096SA SKN17360096SA 2092670-001-518979 00840682109666SKN17360109SA SKN17360109SA 2092670-001-518979 00840682109666SKN17360110SA SKN17360110SA 2092670-001-518979 00840682109666SKN17360111SA SKN17360111SA 2092670-001-518979 00840682109666SKN17370002SA SKN17370002SA 2092670-001-518979 00840682109666SKN17370003SA SKN17370003SA 2092670-001-518979 00840682109666SKN17370004SA SKN17370004SA 2092670-001-518979 00840682109666SKN17370005SA SKN17370005SA 2092670-001-518979 00840682109666SKN17370006SA SKN17370006SA 2092670-001-518979 00840682109666SKN17370007SA SKN17370007SA 2092670-001-518979 00840682109666SKN17370008SA SKN17370008SA 2092670-001-518979 00840682109666SKN17370009SA SKN17370009SA 2092670-001-518979 00840682109666SKN17370010SA SKN17370010SA 2092670-001-518979 00840682109666SKN17370011SA SKN17370011SA 2092670-001-518979 00840682109666SKN17370016SA SKN17370016SA 2092670-001-518979 00840682109666SKN17370017SA SKN17370017SA 2092670-001-518979 00840682109666SKN17370018SA SKN17370018SA 2092670-001-518979 00840682109666SKN17370019SA SKN17370019SA 2092670-001-518979 00840682109666SKN17370020SA SKN17370020SA 2092670-001-518979 00840682109666SKN17370021SA SKN17370021SA 2092670-001-518979 00840682109666SKN17370022SA SKN17370022SA 2092670-001-518979 00840682109666SKN17370023SA SKN17370023SA 2092670-001-518979 00840682109666SKN17370039SA SKN17370039SA 2092670-001-518979 00840682109666SKN17370040SA SKN17370040SA 2092670-001-518979 00840682109666SKN17370041SA SKN17370041SA 2092670-001-518979 00840682109666SKN17370042SA SKN17370042SA 2092670-001-518979 00840682109666SKN17370043SA SKN17370043SA 2092670-001-518979 00840682109666SKN17370044SA SKN17370044SA 2092670-001-518979 00840682109666SKN17370045SA SKN17370045SA 2092670-001-518979 00840682109666SKN17370046SA SKN17370046SA 2092670-001-518979 00840682109666SKN17370047SA SKN17370047SA 2092670-001-518979 00840682109666SKN17370048SA SKN17370048SA 2092670-001-518979 00840682109666SKN17370049SA SKN17370049SA 2092670-001-518979 00840682109666SKN17370050SA SKN17370050SA 2092670-001-518979 00840682109666SKN17370051SA SKN17370051SA 2092670-001-518979 00840682109666SKN17370052SA SKN17370052SA 2092670-001-518979 00840682109666SKN17370054SA SKN17370054SA 2092670-001-518979 00840682109666SKN17370055SA SKN17370055SA 2092670-001-518979 00840682109666SKN17370056SA SKN17370056SA 2092670-001-518979 00840682109666SKN17370057SA SKN17370057SA 2092670-001-518979 00840682109666SKN17370058SA SKN17370058SA 2092670-001-518979 00840682109666SKN17370059SA SKN17370059SA 2092670-001-518979 00840682109666SKN17370064SA SKN17370064SA 2092670-001-518979 00840682109666SKN17370065SA SKN17370065SA 2092670-001-518979 00840682109666SKN17370066SA SKN17370066SA 2092670-001-518979 00840682109666SKN17370067SA SKN17370067SA 2092670-001-518979 00840682109666SKN17370068SA SKN17370068SA 2092670-001-518979 00840682109666SKN17380041SA SKN17380041SA 2092670-001-518979 00840682109666SKN17380049SA SKN17380049SA 2092670-001-518979 00840682109666SKN17380054SA SKN17380054SA 2092670-001-518979 00840682109666SKN17400002SA SKN17400002SA 2092670-001-518979 00840682109666SKN17400003SA SKN17400003SA 2092670-001-518979 00840682109666SKN17410028SA SKN17410028SA 2092670-001-518979 00840682109666SKN17410038SA SKN17410038SA 2092670-001-518979 00840682109666SKN17420107SA SKN17420107SA 2092670-001-518979 00840682109666SKN17420108SA SKN17420108SA 2092670-001-518979 00840682109666SKN17420109SA SKN17420109SA 2092670-001-518979 00840682109666SKN17420110SA SKN17420110SA 2092670-001-518979 00840682109666SKN17420111SA SKN17420111SA 2092670-001-518979 00840682109666SKN17420112SA SKN17420112SA 2092670-001-518979 00840682109666SKN17420113SA SKN17420113SA 2092670-001-518979 00840682109666SKN17420114SA SKN17420114SA 2092670-001-518979 00840682109666SKN17420115SA SKN17420115SA 2092670-001-518979 00840682109666SKN17430009SA SKN17430009SA 2092670-001-518979 00840682109666SKN17450039SA SKN17450039SA 2092670-001-518979 00840682109666SKN17450042SA SKN17450042SA 2092670-001-518979 00840682109666SKN17450043SA SKN17450043SA 2092670-001-518979 00840682109666SKN17450044SA SKN17450044SA 2092670-001-518979 00840682109666SKN17450045SA SKN17450045SA 2092670-001-518979 00840682109666SKN17450046SA SKN17450046SA 2092670-001-518979 00840682109666SKN17450047SA SKN17450047SA 2092670-001-518979 00840682109666SKN17460005SA SKN17460005SA 2092670-001-518979 00840682109666SKN17460006SA SKN17460006SA 2092670-001-518979 00840682109666SKN17460007SA SKN17460007SA 2092670-001-518979 00840682109666SKN17470099SA SKN17470099SA 2092670-001-518979 00840682109666SKN17470100SA SKN17470100SA 2092670-001-518979 00840682109666SKN17510025SA SKN17510025SA 2092670-001-518979 00840682109666SKN17510026SA SKN17510026SA 2092670-001-518979 00840682109666SKN17510027SA SKN17510027SA 2092670-001-519021 00840682109666SKN17290007SA SKN17290007SA 2092670-001-519244 00840682109666SKN17460008SA SKN17460008SA 2092670-001-519246 00840682109666SKN17320029SA SKN17320029SA 2092670-001-519459 00840682109666SKN17300024SA SKN17300024SA 2092670-001-519459 00840682109666SKN17300025SA SKN17300025SA 2092670-001-519459 00840682109666SKN17300026SA SKN17300026SA 2092670-001-519459 00840682109666SKN17300027SA SKN17300027SA 2092670-001-519459 00840682109666SKN17300028SA SKN17300028SA 2092670-001-519459 00840682109666SKN17300029SA SKN17300029SA 2092670-001-519459 00840682109666SKN17300030SA SKN17300030SA 2092670-001-519483 00840682109666SKN17330043SA SKN17330043SA 2092670-001-519483 00840682109666SKN17340074SA SKN17340074SA 2092670-001-519483 00840682109666SKN17350029SA SKN17350029SA 2092670-001-519483 00840682109666SKN17360001SA SKN17360001SA 2092670-001-519483 00840682109666SKN17360004SA SKN17360004SA 2092670-001-519483 00840682109666SKN17360005SA SKN17360005SA 2092670-001-519483 00840682109666SKN17360006SA SKN17360006SA 2092670-001-519483 00840682109666SKN17390056SA SKN17390056SA 2092670-001-519483 00840682109666SKN17390060SA SKN17390060SA 2092670-001-519483 00840682109666SKN17430003SA SKN17430003SA 2092670-001-519483 00840682109666SKN17430005SA SKN17430005SA 2092670-001-519483 00840682109666SKN17430036SA SKN17430036SA 2092670-001-519483 00840682109666SKN17440042SA SKN17440042SA 2092670-001-519483 00840682109666SKN17440043SA SKN17440043SA 2092670-001-519541 00840682109666SKN17310040SA SKN17310040SA 2092670-001-519541 00840682109666SKN17310041SA SKN17310041SA 2092670-001-519541 00840682109666SKN17310042SA SKN17310042SA 2092670-001-519541 00840682109666SKN17310043SA SKN17310043SA 2092670-001-519541 00840682109666SKN17310044SA SKN17310044SA 2092670-001-519541 00840682109666SKN17310045SA SKN17310045SA 2092670-001-519541 00840682109666SKN17310046SA SKN17310046SA 2092670-001-519541 00840682109666SKN17310047SA SKN17310047SA 2092670-001-519541 00840682109666SKN17310048SA SKN17310048SA 2092670-001-519541 00840682109666SKN17310049SA SKN17310049SA 2092670-001-519541 00840682109666SKN17340082SA SKN17340082SA 2092670-001-519541 00840682109666SKN17370075SA SKN17370075SA 2092670-001-519541 00840682109666SKN17380025SA SKN17380025SA 2092670-001-519541 00840682109666SKN17390068SA SKN17390068SA 2092670-001-519541 00840682109666SKN17390069SA SKN17390069SA 2092670-001-519541 00840682109666SKN17430015SA SKN17430015SA 2092670-001-519541 00840682109666SKN17430016SA SKN17430016SA 2092670-001-519541 00840682109666SKN17450024SA SKN17450024SA 2092670-001-519541 00840682109666SKN17490002SA SKN17490002SA 2092670-001-519567 00840682109666SKN17360094SA SKN17360094SA 2092670-001-519567 00840682109666SKN17430007SA SKN17430007SA 2092670-001-519567 00840682109666SKN17430027SA SKN17430027SA 2092670-001-519567 00840682109666SKN17430029SA SKN17430029SA 2092670-001-519567 00840682109666SKN17460012SA SKN17460012SA 2092670-001-519567 00840682109666SKN17460013SA SKN17460013SA 2092670-001-519567 00840682109666SKN17500057SA SKN17500057SA 2092670-001-519572 00840682109666SKN17270016SA SKN17270016SA 2092670-001-519572 00840682109666SKN17270017SA SKN17270017SA 2092670-001-519572 00840682109666SKN17310037SA SKN17310037SA 2092670-001-519572 00840682109666SKN17320040SA 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SKN17500022SA 2092670-001-551636 00840682109666SKN17500023SA SKN17500023SA 2092670-001-551636 00840682109666SKN17500024SA SKN17500024SA 2092670-001-551661 00840682109666SKN17500020SA SKN17500020SA 2092670-001-551662 00840682109666SKN17500021SA SKN17500021SA 2092670-001-551673 00840682109666SKN17490016SA SKN17490016SA 2092670-001-552119 00840682109666SKN17500106SA SKN17500106SA 2092670-001-552284 00840682109666SKN17500008SA SKN17500008SA 2092670-001-552286 00840682109666SKN17500009SA SKN17500009SA 2092670-001-552331 00840682109666SKN17500015SA SKN17500015SA 2092670-001-552331 00840682109666SKN17500016SA SKN17500016SA 2092670-001-552331 00840682109666SKN17500017SA SKN17500017SA 2092670-001-552378 00840682109666SKN17500060SA SKN17500060SA 2092670-001-552557 00840682109666SKN17500018SA SKN17500018SA 2092670-001-553545 00840682109666SKN17510044SA SKN17510044SA 2094314-001-518976 00840682109604SNF16500001SA SNF16500001SA 2094314-001-518976 00840682109604SNF16500002SA SNF16500002SA 2094314-001-518976 00840682109604SNF16500003SA SNF16500003SA 2094314-001-518976 00840682109604SNF16500004SA SNF16500004SA 2094314-001-518976 00840682109604SNF16500005SA SNF16500005SA 2094314-001-520559 00840682109604SNF17460013SA SNF17460013SA 2094314-001-520559 00840682109604SNF17460014SA SNF17460014SA 2094314-001-520559 00840682109604SNF17460015SA SNF17460015SA 2094314-001-520559 00840682109604SNF17460018SA SNF17460018SA 2094314-001-520559 00840682109604SNF17460020SA SNF17460020SA 2094314-001-522924 00840682109604SNF17280006SA SNF17280006SA 2094314-001-522924 00840682109604SNF17280008SA SNF17280008SA 2094314-001-523192 00840682109604SNF17340014SA SNF17340014SA 2094314-001-523192 00840682109604SNF17340015SA SNF17340015SA 2094314-001-523192 00840682109604SNF17340016SA SNF17340016SA 2094314-001-523192 00840682109604SNF17340017SA SNF17340017SA 2094314-001-523192 00840682109604SNF17340018SA SNF17340018SA 2094314-001-523192 00840682109604SNF17350012SA SNF17350012SA 2094314-001-523192 00840682109604SNF17350018SA SNF17350018SA 2094314-001-523192 00840682109604SNF17350019SA SNF17350019SA 2094314-001-523192 00840682109604SNF17390001SA SNF17390001SA 2094314-001-523192 00840682109604SNF17390006SA SNF17390006SA 2094314-001-523192 00840682109604SNF17390007SA SNF17390007SA 2094314-001-523192 00840682109604SNF17390009SA SNF17390009SA 2094314-001-523192 00840682109604SNF17390010SA SNF17390010SA 2094314-001-523192 00840682109604SNF17390011SA SNF17390011SA 2094314-001-523192 00840682109604SNF17390012SA SNF17390012SA 2094314-001-523192 00840682109604SNF17390013SA SNF17390013SA 2094314-001-523192 00840682109604SNF17390014SA SNF17390014SA 2094314-001-523192 00840682109604SNF17390015SA SNF17390015SA 2094314-001-523192 00840682109604SNF17390017SA SNF17390017SA 2094314-001-523192 00840682109604SNF17390018SA SNF17390018SA 2094314-001-523192 00840682109604SNF17390019SA SNF17390019SA 2094314-001-523192 00840682109604SNF17390020SA SNF17390020SA 2094314-001-523192 00840682109604SNF17390021SA SNF17390021SA 2094314-001-523192 00840682109604SNF17390023SA SNF17390023SA 2094314-001-523192 00840682109604SNF17390024SA SNF17390024SA 2094314-001-523192 00840682109604SNF17390025SA SNF17390025SA 2094314-001-523192 00840682109604SNF17390026SA SNF17390026SA 2094314-001-523192 00840682109604SNF17390027SA SNF17390027SA 2094314-001-523192 00840682109604SNF17390028SA SNF17390028SA 2094314-001-523192 00840682109604SNF17390029SA SNF17390029SA 2094314-001-523192 00840682109604SNF17390030SA SNF17390030SA 2094314-001-523192 00840682109604SNF17390031SA SNF17390031SA 2094314-001-523192 00840682109604SNF17390032SA SNF17390032SA 2094314-001-523192 00840682109604SNF17390033SA SNF17390033SA 2094314-001-523192 00840682109604SNF17390034SA SNF17390034SA 2094314-001-523192 00840682109604SNF17390035SA SNF17390035SA 2094314-001-523192 00840682109604SNF17390036SA SNF17390036SA 2094314-001-523192 00840682109604SNF17390037SA SNF17390037SA 2094314-001-523192 00840682109604SNF17390038SA SNF17390038SA 2094314-001-523192 00840682109604SNF17390039SA SNF17390039SA 2094314-001-523192 00840682109604SNF17390040SA SNF17390040SA 2094314-001-523192 00840682109604SNF17390041SA SNF17390041SA 2094314-001-523192 00840682109604SNF17390042SA SNF17390042SA 2094314-001-523192 00840682109604SNF17390043SA SNF17390043SA 2094314-001-523192 00840682109604SNF17390044SA SNF17390044SA 2094314-001-523192 00840682109604SNF17390045SA SNF17390045SA 2094314-001-523192 00840682109604SNF17390046SA SNF17390046SA 2094314-001-523192 00840682109604SNF17390047SA SNF17390047SA 2094314-001-523192 00840682109604SNF17390048SA SNF17390048SA 2094314-001-523192 00840682109604SNF17410007SA SNF17410007SA 2094314-001-523192 00840682109604SNF17410008SA SNF17410008SA 2094314-001-523192 00840682109604SNF17410010SA SNF17410010SA 2094314-001-523192 00840682109604SNF17420001SA SNF17420001SA 2094314-001-523192 00840682109604SNF17420003SA SNF17420003SA 2094314-001-523192 00840682109604SNF17420006SA SNF17420006SA 2094314-001-523192 00840682109604SNF17420007SA SNF17420007SA 2094314-001-523192 00840682109604SNF17420008SA SNF17420008SA 2094314-001-523192 00840682109604SNF17420010SA SNF17420010SA 2094314-001-523192 00840682109604SNF17420011SA SNF17420011SA 2094314-001-523192 00840682109604SNF17420012SA SNF17420012SA 2094314-001-523192 00840682109604SNF17420013SA SNF17420013SA 2094314-001-523192 00840682109604SNF17420014SA SNF17420014SA 2094314-001-523192 00840682109604SNF17420015SA SNF17420015SA 2094314-001-523192 00840682109604SNF17420016SA SNF17420016SA 2094314-001-523192 00840682109604SNF17420017SA SNF17420017SA 2094314-001-523192 00840682109604SNF17420018SA SNF17420018SA 2094314-001-523192 00840682109604SNF17420019SA SNF17420019SA 2094314-001-523192 00840682109604SNF17420020SA SNF17420020SA 2094314-001-523192 00840682109604SNF17420021SA SNF17420021SA 2094314-001-523192 00840682109604SNF17420023SA SNF17420023SA 2094314-001-523192 00840682109604SNF17420024SA SNF17420024SA 2094314-001-523192 00840682109604SNF17420027SA SNF17420027SA 2094314-001-523192 00840682109604SNF17420028SA SNF17420028SA 2094314-001-523192 00840682109604SNF17420029SA SNF17420029SA 2094314-001-523192 00840682109604SNF17420030SA SNF17420030SA 2094314-001-523192 00840682109604SNF17420031SA SNF17420031SA 2094314-001-523192 00840682109604SNF17420032SA SNF17420032SA 2094314-001-523192 00840682109604SNF17420033SA SNF17420033SA 2094314-001-523192 00840682109604SNF17420034SA SNF17420034SA 2094314-001-523192 00840682109604SNF17420035SA SNF17420035SA 2094314-001-523192 00840682109604SNF17420036SA SNF17420036SA 2094314-001-523192 00840682109604SNF17420037SA SNF17420037SA 2094314-001-523192 00840682109604SNF17420038SA SNF17420038SA 2094314-001-523192 00840682109604SNF17420039SA SNF17420039SA 2094314-001-523192 00840682109604SNF17420040SA SNF17420040SA 2094314-001-523192 00840682109604SNF17420041SA SNF17420041SA 2094314-001-523192 00840682109604SNF17420042SA SNF17420042SA 2094314-001-523192 00840682109604SNF17420043SA SNF17420043SA 2094314-001-523192 00840682109604SNF17430003SA SNF17430003SA 2094314-001-523192 00840682109604SNF17440004SA SNF17440004SA 2094314-001-523192 00840682109604SNF17440005SA SNF17440005SA 2094314-001-523192 00840682109604SNF17500072SA SNF17500072SA 2094314-001-523192 00840682109604SNF17510011SA SNF17510011SA 2094314-001-523602 00840682109604SNF17380004SA SNF17380004SA 2094314-001-523602 00840682109604SNF17380007SA SNF17380007SA 2094314-001-523617 00840682109604SNF17350020SA SNF17350020SA 2094314-001-523617 00840682109604SNF17370007SA SNF17370007SA 2094314-001-523618 00840682109604SNF17350013SA SNF17350013SA 2094314-001-523618 00840682109604SNF17380002SA SNF17380002SA 2094314-001-523618 00840682109604SNF17420002SA SNF17420002SA 2094314-001-523883 00840682109604SNF17390003SA SNF17390003SA 2094314-001-523883 00840682109604SNF17400004SA SNF17400004SA 2094314-001-523883 00840682109604SNF17400005SA SNF17400005SA 2094314-001-524464 00840682109604SNF17450053SA SNF17450053SA 2094314-001-524464 00840682109604SNF17450054SA SNF17450054SA 2094314-001-524573 00840682109604SNF17360016SA SNF17360016SA 2094314-001-525431 00840682109604SNF17500031SA SNF17500031SA 2094314-001-525523 00840682109604SNF17430012SA SNF17430012SA 2094314-001-525550 00840682109604SNF17350016SA SNF17350016SA 2094314-001-525550 00840682109604SNF17350017SA SNF17350017SA 2094314-001-525551 00840682109604SNF17350010SA SNF17350010SA 2094314-001-525552 00840682109604SNF17390005SA SNF17390005SA 2094314-001-525553 00840682109604SNF17350014SA SNF17350014SA 2094314-001-525554 00840682109604SNF17350015SA SNF17350015SA 2094314-001-525555 00840682109604SNF17350009SA SNF17350009SA 2094314-001-525719 00840682109604SNF17130020SA SNF17130020SA 2094314-001-525719 00840682109604SNF17130021SA SNF17130021SA 2094314-001-525743 00840682109604SNF17280001SA SNF17280001SA 2094314-001-526560 00840682109604SNF17330019SA SNF17330019SA 2094314-001-526562 00840682109604SNF17330020SA SNF17330020SA 2094314-001-526562 00840682109604SNF17330021SA SNF17330021SA 2094314-001-526562 00840682109604SNF17330022SA SNF17330022SA 2094314-001-528307 00840682109604SNF17430005SA SNF17430005SA 2094314-001-528307 00840682109604SNF17430006SA SNF17430006SA 2094314-001-532041 00840682109604SNF17260009SA SNF17260009SA 2094314-001-532041 00840682109604SNF17260010SA SNF17260010SA 2094314-001-532041 00840682109604SNF17260011SA SNF17260011SA 2094314-001-532041 00840682109604SNF17260012SA SNF17260012SA 2094314-001-532041 00840682109604SNF17260013SA SNF17260013SA 2094314-001-532041 00840682109604SNF17260014SA SNF17260014SA 2094314-001-532041 00840682109604SNF17340019SA SNF17340019SA 2094314-001-532041 00840682109604SNF17340020SA SNF17340020SA 2094314-001-532041 00840682109604SNF17340021SA SNF17340021SA 2094314-001-532041 00840682109604SNF17340022SA SNF17340022SA 2094314-001-532041 00840682109604SNF17340023SA SNF17340023SA 2094314-001-532041 00840682109604SNF17340024SA SNF17340024SA 2094314-001-532147 00840682109604SNF17410016SA SNF17410016SA 2094314-001-532147 00840682109604SNF17410020SA SNF17410020SA 2094314-001-532147 00840682109604SNF17420005SA SNF17420005SA 2094314-001-532147 00840682109604SNF17420009SA SNF17420009SA 2094314-001-532147 00840682109604SNF17440001SA SNF17440001SA 2094314-001-532147 00840682109604SNF17440002SA SNF17440002SA 2094314-001-532147 00840682109604SNF17440003SA SNF17440003SA 2094314-001-533246 00840682109604SNF17330006SA SNF17330006SA 2094314-001-533246 00840682109604SNF17430007SA SNF17430007SA 2094314-001-533246 00840682109604SNF17430008SA SNF17430008SA 2094314-001-533247 00840682109604SNF17320013SA SNF17320013SA 2094314-001-533247 00840682109604SNF17440006SA SNF17440006SA 2094314-001-533247 00840682109604SNF17440007SA SNF17440007SA 2094314-001-535542 00840682109604SNF17230006SA SNF17230006SA 2094314-001-535634 00840682109604SNF17230005SA SNF17230005SA 2094314-001-535695 00840682109604SNF17290016SA SNF17290016SA 2094314-001-535799 00840682109604SNF17280009SA SNF17280009SA 2094314-001-535799 00840682109604SNF17280010SA SNF17280010SA 2094314-001-535930 00840682109604SNF17330007SA SNF17330007SA 2094314-001-535930 00840682109604SNF17330008SA SNF17330008SA 2094314-001-535930 00840682109604SNF17330009SA SNF17330009SA 2094314-001-536000 00840682109604SNF17430010SA SNF17430010SA 2094314-001-536000 00840682109604SNF17440009SA SNF17440009SA 2094314-001-536000 00840682109604SNF17440010SA SNF17440010SA 2094314-001-536000 00840682109604SNF17450059SA SNF17450059SA 2094314-001-536188 00840682109604SNF17370008SA SNF17370008SA 2094314-001-536188 00840682109604SNF17370009SA SNF17370009SA 2094314-001-536331 00840682109604SNF17240020SA SNF17240020SA 2094314-001-536412 00840682109604SNF17290014SA SNF17290014SA 2094314-001-536412 00840682109604SNF17290015SA SNF17290015SA 2094314-001-536667 00840682109604SNF17320008SA SNF17320008SA 2094314-001-536792 00840682109604SNF17320009SA SNF17320009SA 2094314-001-537245 00840682109604SNF17320010SA SNF17320010SA 2094314-001-537246 00840682109604SNF17320011SA SNF17320011SA 2094314-001-537251 00840682109604SNF17260024SA SNF17260024SA 2094314-001-537322 00840682109604SNF17260028SA SNF17260028SA 2094314-001-537359 00840682109604SNF17270001SA SNF17270001SA 2094314-001-537596 00840682109604SNF17330005SA SNF17330005SA 2094314-001-537666 00840682109604SNF17330011SA SNF17330011SA 2094314-001-537667 00840682109604SNF17330010SA SNF17330010SA 2094314-001-537668 00840682109604SNF17320014SA SNF17320014SA 2094314-001-537669 00840682109604SNF17320018SA SNF17320018SA 2094314-001-537669 00840682109604SNF17320019SA SNF17320019SA 2094314-001-537772 00840682109604SNF17460019SA SNF17460019SA 2094314-001-538056 00840682109604SNF17330004SA SNF17330004SA 2094314-001-538134 00840682109604SNF17280011SA SNF17280011SA 2094314-001-538135 00840682109604SNF17290001SA SNF17290001SA 2094314-001-538136 00840682109604SNF17290008SA SNF17290008SA 2094314-001-538137 00840682109604SNF17290010SA SNF17290010SA 2094314-001-538350 00840682109604SNF17350022SA SNF17350022SA 2094314-001-538472 00840682109604SNF17390050SA SNF17390050SA 2094314-001-538473 00840682109604SNF17390051SA SNF17390051SA 2094314-001-538476 00840682109604SNF17320003SA SNF17320003SA 2094314-001-538476 00840682109604SNF17320004SA SNF17320004SA 2094314-001-538476 00840682109604SNF17320005SA SNF17320005SA 2094314-001-538476 00840682109604SNF17320006SA SNF17320006SA 2094314-001-538476 00840682109604SNF17320007SA SNF17320007SA 2094314-001-538476 00840682109604SNF17320022SA SNF17320022SA 2094314-001-538476 00840682109604SNF17320027SA SNF17320027SA 2094314-001-538476 00840682109604SNF17320030SA SNF17320030SA 2094314-001-538476 00840682109604SNF17320031SA SNF17320031SA 2094314-001-538476 00840682109604SNF17340003SA SNF17340003SA 2094314-001-538476 00840682109604SNF17340005SA SNF17340005SA 2094314-001-538476 00840682109604SNF17340006SA SNF17340006SA 2094314-001-538476 00840682109604SNF17340008SA SNF17340008SA 2094314-001-538476 00840682109604SNF17370004SA SNF17370004SA 2094314-001-538476 00840682109604SNF17370005SA SNF17370005SA 2094314-001-538587 00840682109604SNF17290002SA SNF17290002SA 2094314-001-538587 00840682109604SNF1729003SA SNF1729003SA 2094314-001-538588 00840682109604SNF17290009SA SNF17290009SA 2094314-001-538771 00840682109604SNF17340007SA SNF17340007SA 2094314-001-538774 00840682109604SNF17340013SA SNF17340013SA 2094314-001-538910 00840682109604SNF17450060SA SNF17450060SA 2094314-001-538978 00840682109604SNF17340027SA SNF17340027SA 2094314-001-539062 00840682109604SNF17310001SA SNF17310001SA 2094314-001-539099 00840682109604SNF17330012SA SNF17330012SA 2094314-001-539179 00840682109604SNF17320016SA SNF17320016SA 2094314-001-539179 00840682109604SNF17320017SA SNF17320017SA 2094314-001-539409 00840682109604SNF17320002SA SNF17320002SA 2094314-001-539489 00840682109604SNF17320032SA SNF17320032SA 2094314-001-539743 00840682109604SNF17320015SA SNF17320015SA 2094314-001-539842 00840682109604SNF17320020SA SNF17320020SA 2094314-001-539842 00840682109604SNF17370006SA SNF17370006SA 2094314-001-539843 00840682109604SNF17320028SA SNF17320028SA 2094314-001-539843 00840682109604SNF17380003SA SNF17380003SA 2094314-001-539947 00840682109604SNF17320001SA SNF17320001SA 2094314-001-539974 00840682109604SNF17320024SA SNF17320024SA 2094314-001-539975 00840682109604SNF17320012SA SNF17320012SA 2094314-001-539983 00840682109604SNF17330013SA SNF17330013SA 2094314-001-539983 00840682109604SNF17330014SA SNF17330014SA 2094314-001-539983 00840682109604SNF17330015SA SNF17330015SA 2094314-001-539983 00840682109604SNF17330016SA SNF17330016SA 2094314-001-540189 00840682109604SNF17320025SA SNF17320025SA 2094314-001-540190 00840682109604SNF17330001SA SNF17330001SA 2094314-001-540505 00840682109604SNF17350006SA SNF17350006SA 2094314-001-540505 00840682109604SNF17350007SA SNF17350007SA 2094314-001-540667 00840682109604SNF17390004SA SNF17390004SA 2094314-001-540683 00840682109604SNF17330017SA SNF17330017SA 2094314-001-540773 00840682109604SNF17340001SA SNF17340001SA 2094314-001-540773 00840682109604SNF17340004SA SNF17340004SA 2094314-001-540775 00840682109604SNF17340002SA SNF17340002SA 2094314-001-540790 00840682109604SNF17350011SA SNF17350011SA 2094314-001-540790 00840682109604SNF17450063SA SNF17450063SA 2094314-001-540790 00840682109604SNF17450065SA SNF17450065SA 2094314-001-540821 00840682109604SNF17340028SA SNF17340028SA 2094314-001-540821 00840682109604SNF17360032SA SNF17360032SA 2094314-001-540821 00840682109604SNF17500015SA SNF17500015SA 2094314-001-540821 00840682109604SNF17500016SA SNF17500016SA 2094314-001-540821 00840682109604SNF17500017SA SNF17500017SA 2094314-001-540821 00840682109604SNF17500018SA SNF17500018SA 2094314-001-540941 00840682109604SNF17400001SA SNF17400001SA 2094314-001-541247 00840682109604SNF17350001SA SNF17350001SA 2094314-001-541247 00840682109604SNF17350002SA SNF17350002SA 2094314-001-541247 00840682109604SNF17350003SA SNF17350003SA 2094314-001-541247 00840682109604SNF17350004SA SNF17350004SA 2094314-001-541247 00840682109604SNF17350005SA SNF17350005SA 2094314-001-541256 00840682109604SNF17410002SA SNF17410002SA 2094314-001-541392 00840682109604SNF17350021SA SNF17350021SA 2094314-001-541392 00840682109604SNF17460001SA SNF17460001SA 2094314-001-541392 00840682109604SNF17470008SA SNF17470008SA 2094314-001-541392 00840682109604SNF17500004SA SNF17500004SA 2094314-001-541392 00840682109604SNF17500007SA SNF17500007SA 2094314-001-541392 00840682109604SNF17500008SA SNF17500008SA 2094314-001-541736 00840682109604SNF17380129SA SNF17380129SA 2094314-001-541746 00840682109604SNF17370003SA SNF17370003SA 2094314-001-541920 00840682109604SNF17370002SA SNF17370002SA 2094314-001-542055 00840682109604SNF17370001SA SNF17370001SA 2094314-001-542358 00840682109604SNF17360031SA SNF17360031SA 2094314-001-543240 00840682109604SNF17390052SA SNF17390052SA 2094314-001-543432 00840682109604SNF17390049SA SNF17390049SA 2094314-001-543542 00840682109604SNF17380001SA SNF17380001SA 2094314-001-543591 00840682109604SNF17380006SA SNF17380006SA 2094314-001-544211 00840682109604SNF17410011SA SNF17410011SA 2094314-001-544211 00840682109604SNF17410014SA SNF17410014SA 2094314-001-544214 00840682109604SNF17410012SA SNF17410012SA 2094314-001-544269 00840682109604SNF17500041SA SNF17500041SA 2094314-001-544309 00840682109604SNF17400002SA SNF17400002SA 2094314-001-544426 00840682109604SNF17390054SA SNF17390054SA 2094314-001-544468 00840682109604SNF17390053SA SNF17390053SA 2094314-001-544754 00840682109604SNF17410009SA SNF17410009SA 2094314-001-544755 00840682109604SNF17410003SA SNF17410003SA 2094314-001-544762 00840682109604SNF17400003SA SNF17400003SA 2094314-001-544871 00840682109604SNF17400006SA SNF17400006SA 2094314-001-544877 00840682109604SNF17430011SA SNF17430011SA 2094314-001-544931 00840682109604SNF17500061SA SNF17500061SA 2094314-001-544931 00840682109604SNF17500062SA SNF17500062SA 2094314-001-544931 00840682109604SNF17500063SA SNF17500063SA 2094314-001-544931 00840682109604SNF17500064SA SNF17500064SA 2094314-001-544931 00840682109604SNF17500065SA SNF17500065SA 2094314-001-544932 00840682109604SNF17400007SA SNF17400007SA 2094314-001-544932 00840682109604SNF17400008SA SNF17400008SA 2094314-001-544932 00840682109604SNF17400009SA SNF17400009SA 2094314-001-544932 00840682109604SNF17400012SA SNF17400012SA 2094314-001-544932 00840682109604SNF17400013SA SNF17400013SA 2094314-001-544932 00840682109604SNF17400014SA SNF17400014SA 2094314-001-544932 00840682109604SNF17400015SA SNF17400015SA 2094314-001-545690 00840682109604SNF17410013SA SNF17410013SA 2094314-001-545691 00840682109604SNF17420004SA SNF17420004SA 2094314-001-545691 00840682109604SNF17440008SA SNF17440008SA 2094314-001-545692 00840682109604SNF17410001SA SNF17410001SA 2094314-001-546131 00840682109604SNF17410023SA SNF17410023SA 2094314-001-546143 00840682109604SNF17410024SA SNF17410024SA 2094314-001-546143 00840682109604SNF17410025SA SNF17410025SA 2094314-001-546400 00840682109604SNF17440011SA SNF17440011SA 2094314-001-546401 00840682109604SNF17450012SA SNF17450012SA 2094314-001-547857 00840682109604SNF17430004SA SNF17430004SA 2094314-001-548334 00840682109604SNF17430013SA SNF17430013SA 2094314-001-548335 00840682109604SNF17450001SA SNF17450001SA 2094314-001-548396 00840682109604SNF17430009SA SNF17430009SA 2094314-001-548764 00840682109604SNF17450017SA SNF17450017SA 2094314-001-548764 00840682109604SNF17450018SA SNF17450018SA 2094314-001-548992 00840682109604SNF17500001SA SNF17500001SA 2094314-001-549062 00840682109604SNF17450002SA SNF17450002SA 2094314-001-549062 00840682109604SNF17450003SA SNF17450003SA 2094314-001-549062 00840682109604SNF17450004SA SNF17450004SA 2094314-001-549062 00840682109604SNF17450005SA SNF17450005SA 2094314-001-549062 00840682109604SNF17450006SA SNF17450006SA 2094314-001-549062 00840682109604SNF17450007SA SNF17450007SA 2094314-001-549202 00840682109604SNF17510003SA SNF17510003SA 2094314-001-549202 00840682109604SNF17510004SA SNF17510004SA 2094314-001-549376 00840682109604SNF17450011SA SNF17450011SA 2094314-001-549376 00840682109604SNF17450056SA SNF17450056SA 2094314-001-549376 00840682109604SNF17450057SA SNF17450057SA 2094314-001-549532 00840682109604SNF17450064SA SNF17450064SA 2094314-001-549576 00840682109604SNF17450061SA SNF17450061SA 2094314-001-549578 00840682109604SNF17450062SA SNF17450062SA 2094314-001-549647 00840682109604SNF17500059SA SNF17500059SA 2094314-001-549691 00840682109604SNF17510012SA SNF17510012SA 2094314-001-549803 00840682109604SNF17460002SA SNF17460002SA 2094314-001-549803 00840682109604SNF17460003SA SNF17460003SA 2094314-001-549803 00840682109604SNF17460009SA SNF17460009SA 2094314-001-549803 00840682109604SNF17460010SA SNF17460010SA 2094314-001-549803 00840682109604SNF17460011SA SNF17460011SA 2094314-001-549803 00840682109604SNF17460012SA SNF17460012SA 2094314-001-550083 00840682109604SNF17460021SA SNF17460021SA 2094314-001-550083 00840682109604SNF17460022SA SNF17460022SA 2094314-001-550083 00840682109604SNF17460023SA SNF17460023SA 2094314-001-550083 00840682109604SNF17460024SA SNF17460024SA 2094314-001-550083 00840682109604SNF17460025SA SNF17460025SA 2094314-001-550083 00840682109604SNF17460026SA SNF17460026SA 2094314-001-550083 00840682109604SNF17460027SA SNF17460027SA 2094314-001-550203 00840682109604SNF17470004SA SNF17470004SA 2094314-001-550301 00840682109604SNF17470002SA SNF17470002SA 2094314-001-550622 00840682109604SNF17470003SA SNF17470003SA 2094314-001-550622 00840682109604SNF17500003SA SNF17500003SA 2094314-001-550722 00840682109604SNF17470007SA SNF17470007SA 2094314-001-551297 00840682109604SNF17500009SA SNF17500009SA 2094314-001-551297 00840682109604SNF17500010SA SNF17500010SA 2094314-001-551312 00840682109604SNF17500011SA SNF17500011SA 2094314-001-551312 00840682109604SNF17500012SA SNF17500012SA 2094314-001-551312 00840682109604SNF17500013SA SNF17500013SA 2094314-001-551312 00840682109604SNF17500014SA SNF17500014SA 2094314-001-551779 00840682109604SNF17510018SA SNF17510018SA 2094314-001-551779 00840682109604SNF17510019SA SNF17510019SA 2094314-001-551779 00840682109604SNF17510020SA SNF17510020SA 2094314-001-551859 00840682109604SNF17500032SA SNF17500032SA 2094314-001-551859 00840682109604SNF17500033SA SNF17500033SA 2094314-001-551859 00840682109604SNF17500034SA SNF17500034SA 2094314-001-552242 00840682109604SNF17500022SA SNF17500022SA 2094314-001-553138 00840682109604SNF17500006SA SNF17500006SA 2094314-001-553739 00840682109604SNF17510070SA SNF17510070SA 2094314-001-553739 00840682109604SNF17510071SA SNF17510071SA 2094314-001-553739 00840682109604SNF17510072SA SNF17510072SA 2094314-001-553739 00840682109604SNF17510080SA SNF17510080SA 2094314-001-553739 00840682109604SNF17510081SA SNF17510081SA 2094314-001-553739 00840682109604SNF17510083SA SNF17510083SA 2094314-001-553741 00840682109604SNF17510077SA SNF17510077SA 2094314-001-553741 00840682109604SNF17510078SA SNF17510078SA 2094314-001-553741 00840682109604SNF17510079SA SNF17510079SA 2099146-001-535105 00840682109604SNF17340011SA SNF17340011SA 2099146-001-539645 00840682109604SNF17340009SA SNF17340009SA 2099146-001-539645 00840682109604SNF17340010SA SNF17340010SA 2099146-001-539645 00840682109604SNF17340012SA SNF17340012SA   
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee WI 53223-3219
For Additional Information Contact
800-558-7044
Manufacturer Reason
for Recall		 CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
FDA Determined
Cause 2		 Software in the Use Environment
Action The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.
Quantity in Commerce 1803 units
Distribution Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = GE HEALTHCARE
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