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U.S. Department of Health and Human Services

Class 2 Device Recall Definium Tempo

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  Class 2 Device Recall Definium Tempo see related information
Date Initiated by Firm November 07, 2023
Date Posted December 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-0552-2024
Recall Event ID 93479
510(K)Number K191699  
Product Classification System, x-ray, stationary - Product Code KPR
Product The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices.
The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
Code Information UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1; UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1; UDI 01001952781183561122110021DX3SS2200216HL, System ID 623ABZARRWTMPO; UDI 01001952781183561122120021DX3SS2300001HL, System ID 928263DEF1; UDI 01001952781183561123040021DX3SS2300103HL, System ID 520NOGTEMPO; UDI 01001952781183561122100021DX3SS2200210HL, System ID 602ABZSCOTTSTMPO; UDI 01001952781183561122110021DX3SS2200223HL, System ID 602ABZCNTRLTMPO; UDI 01001952781183561123030021DX3SS2300082HL, System ID 209324DEF1; UDI 01001952781183561123020021DX3SS2300046HL, System ID 209497DEF1; UDI 01001952781183561122080021DX3SS2200158HL, System ID 303827DEF1; UDI 01001952781183561123010021DX3SS2300030HL, System ID 970242DEF1; UDI 01001952781183561122080021DX3SS2200168HL, System ID 303457DEF1; UDI 01001952781183561122030021DX3SS2200047HL, System ID 860545TEMPO1; UDI 01001952781183561122030021DX3SS2200046HL, System ID 860545TEMPO2; UDI 01001952781183561122010021DX3SS2200013HL, System ID 203838TEMPO; UDI 01001952781183561122070021DX3SS2200117HL, System ID 860889TEMPO; UDI 01001952781183561123010021DX3SS2300013HL, System ID 202444DEF2; UDI 01001952781183561123040021DX3SS2300135HL, System ID 202877TEM1; UDI 01001952781183561123020021DX3SS2300039HL, System ID 813681DEF1; UDI 01001952780702651122030021DX3SS2200032HL, System ID AHMGCTEM1; UDI 01001952781183561123030021DX3SS2300098HL, System ID 305222DEF1; UDI 01001952781183561122110021DX3SS2200228HL, System ID 561495DEF1; UDI 01001952781183561123020021DX3SS2100173HL, System ID MDEDTEMPO; UDI 01001952781183561122120021DX3SS2200265HL, System ID 407530DEF1; UDI 01001952781183561123020021DX3SS2300041HL, System ID 863680TEMP; UDI 01001952781183561122080021DX3SS2200128HL, System ID 305DLTEMPO; UDI 01001952781183561122070021DX3SS2200113HL, System ID 904BURGRAD1; UDI 01001952781183561123050021DX3SS2300145HL, System ID 407269DEF1; UDI 01001952781183561123030021DX3SS2300080HL, System ID NAEDTEMPO; UDI 01001952781183561122100021DX3SS2200199HL, System ID 561514DEF1; UDI 01001952781183561122110021DX3SS2200215HL, System ID 850DEFBP; UDI 01001952781183561123020021DX3SS2300053HL, System ID 727300DEF; UDI 01001952781183561123080021DX3SS2300211HL, System ID 404251DEF2; UDI Not Available, System ID 912530OPT; UDI 01001952781183561122110021DX3SS2200243HL, System ID 404778STKTEM1; UDI 01001952781183561122080021DX3SS2200156HL, System ID 804333DEF1; UDI 01001952781183561122100021DX3SS2200185HL, System ID 208265DEF1; UDI 01001952781183561122080021DX3SS2200141HL, System ID NMNMHTEMP1; UDI 01001952781183561122050021DX3SS2200071HL, System ID 847842TEMP; UDI 01001952781183561122070021DX3SS2200115HL, System ID 765298DEF1; UDI 01001952781183561122050021DX3SS2200081HL, System ID 317887TEMPO; UDI 01001952781183561122120021DX3SS2200262HL, System ID 317621DEF1; UDI 01001952781183561122090021DX3SS2200174HL, System ID 812283DEF1; UDI 01001952781183561122050021DX3SS2200063HL, System ID 785877DEF1; UDI 01001952781183561123060021DX3SS2300164HL, System ID 913588TEMPO; UDI 01001952781183561122080021DX3SS2200162HL, System ID 337261DEF1; UDI 01001952781183561122100021DX3SS2200189HL, System ID 337261DEF2; UDI 01001952781183561122100021DX3SS2200191HL, System ID 508363TEMPO; UDI 01001952781183561122100021DX3SS2200203HL, System ID 269789DEF1; UDI 01001952781183561122110021DX3SS2200239HL, System ID 248937DEF1; UDI 01001952781183561122110021DX3SS2200227HL, System ID 313820DEF1; UDI 01001952781183561122110021DX3SS2200238HL, System ID 313966DEF1; UDI 01001952781183561122120021DX3SS2200253HL, System ID 734712DEF; UDI 01001952781183561122080021DX3SS2200135HL, System ID 601288DEFTEMPO; UDI 01001952781183561123010021DX3SS2300011HL, System ID 406375DEFTEM; UDI 01001952781183561123070021DX3SS2300182HL, System ID 828376TEMPOXR; UDI 01001952781183561123030021DX3SS2300087HL, System ID 828766BRTEMPO; UDI 01001952781183561122050021DX3SS2200065HL, System ID 701567TEMPO; UDI 01001952781183561123060021DX3SS2300165HL, System ID 605310DEF1; UDI 01001952781183561122110021DX3SS2200232HL, System ID 800439DEFTEM; UDI 01001952781183561123040021DX3SS2300126HL, System ID 603432PLATEMP; UDI 01001952781183561123040021DX3SS2300127HL, System ID 609463DEF1; UDI 01001952781183561121070021DX3SS2100170HL, System ID 914787XRA; UDI 01001952781183561123040021DX3SS2300117HL, System ID 716597DEF1; UDI 01001952781183561122020021DX3SS2200021HL, System ID 631CMKTEMPO; UDI 01001952781183561123020021DX3SS2300036HL, System ID 607273TEMPO1; UDI 01001952781183561122050021DX3SS2200075HL, System ID 716664TEMPO; UDI 01001952781183561122070021DX3SS2200112HL, System ID 607337DEF11; UDI Not Available, System ID 585922DEF; UDI 01001952781183561122020021DX3SS2200023HL, System ID 631638TEMPO; UDI 01001952781183561122070021DX3SS2200120HL, System ID 419483TEMPO1; UDI 01001952781183561123040021DX3SS2300106HL, System ID 330721DEF1; UDI 01001952781183561122020021DX3SS2200025HL, System ID 937523TEMPO; UDI 01001952781183561123040021DX3SS2300107HL, System ID 419578TEMPO1; UDI 01001952781183561122050021DX3SS2200076HL, System ID 405951TEMPO; UDI 01001952781183561122050021DX3SS2200080HL, System ID 405271TEMPO; UDI 01001952781183561122100021DX3SS2200193HL, System ID 405271AHTEMPO; UDI 01001952781183561121080021DX3SS2100204HL, System ID SLATEMPO; UDI 01001952781183561122070021DX3SS2200123HL, System ID SLSMITHTEMPO; UDI 01001952781183561122100021DX3SS2200186HL, System ID 717231TEMPO; UDI 01001952781183561122080021DX3SS2200157HL, System ID SLKTEMPO; UDI 01001952781183561121120021DX3SS2100280HL, System ID LVPGLTEMPO; UDI 01001952781183561122110021DX3SS2200245HL, System ID 717656TEMPO; UDI 01001952781183561122050021DX3SS2200079HL, System ID 272639TEMPO; UDI 01001952781183561122050021DX3SS2200064HL, System ID 570723TEMPOER; UDI 01001952781183561123030021DX3SS2300088HL, System ID 843782TEMPO1; UDI 01001952781183561122110021DX3SS2200234HL, System ID 843784DEF1; UDI 01001952781183561122100021DX3SS2200204HL, System ID 843442DEF1; UDI 01001952781183561122010021DX3SS2200005HL, System ID 605997RADT; UDI 01001952781183561122080021DX3SS2200143HL, System ID 605835TEMPO; UDI 01001952781183561123050021DX3SS2300159HL, System ID 605995DEF1; UDI 01001952781183561122060021DX3SS2200098HL, System ID 605328TEMPO; UDI 01001952781183561122080021DX3SS2200147HL, System ID 605589DEF1; UDI 01001952781183561123060021DX3SS2300168HL, System ID 423855DEF1; UDI 01001952781183561122100021DX3SS2200206HL, System ID 615781DEF1; UDI 01001952781183561122120021DX3SS2200254HL, System ID 615316DEF1; UDI 01001952781183561123030021DX3SS2300066HL, System ID 865980DEF1; UDI 01001952781183561122120021DX3SS2200264HL, System ID 423492DEF1; UDI 01001952781183561123010021DX3SS2300024HL, System ID 423492DEF2; UDI 01001952781183561123060021DX3SS2300170HL, System ID 817SATEMPO; UDI 01001952781183561122110021DX3SS2200231HL, System ID 956564DEF1; UDI 01001952781183561123070021DX3SS2300181HL, System ID 214276EIDTEMPO; UDI 01001952781183561122100021DX3SS2200207HL, System ID 915747DEF1; UDI 01001952781183561122110021DX3SS2200235HL, System ID 915832DEF2; UDI 01001952781183561122060021DX3SS2200095HL, System ID 915832DEF1; UDI 01001952781183561122080021DX3SS2200129HL, System ID 817MCHTEMPO; UDI 01001952781183561123050021DX3SS2300141HL, System ID 214483TEMPO; UDI 01001952781183561122090021DX3SS2200182HL, System ID 281348DEF1; UDI 01001952781183561123010021DX3SS2300008HL, System ID 956342DEF1; UDI 01001952781183561122030021DX3SS2200039HL, System ID 830MERTEMPO; UDI 01001952781183561122050021DX3SS2200060HL, System ID 903737PRDTEMPO; UDI 01001952781183561122100021DX3SS2200196HL, System ID 210SLBTEMPO; UDI 01001952781183561122110021DX3SS2200219HL, System ID 210MTBTEMPO; UDI 01001952781183561122110021DX3SS2200218HL, System ID 210NCBTEMPO; UDI 01001952781183561122110021DX3SS2200226HL, System ID 210BMCTEMPO; UDI 01001952781183561123040021DX3SS2300130HL, System ID 817424TEMPO; UDI 01001952781183561123060021DX3SS2300163HL, System ID 435635DEF; UDI 01001952781183561122030021DX3SS2200041HL, System ID 435587DEF; UDI 01001952781183561122120021DX3SS2200249HL, System ID 801726DEF1; UDI 01001952781183561122060021DX3SS2200099HL, System ID 801372DEF1; UDI 01001952781183561122100021DX3SS2200190HL, System ID 435658DEF1; UDI 01001952781183561123010021DX3SS2300034HL, System ID 801726DEF2; UDI 01001952781183561123050021DX3SS2300140HL, System ID 801268DEF; UDI 01001952781183561123060021DX3SS2300162HL, System ID 801840DEF1; UDI 01001952781183561122040021DX3SS2200059HL, System ID 801855DEF1; UDI 01001952781183561121090021DX3SS2100254HL, System ID 703751DEF; UDI 01001952781183561122070021DX3SS2200116HL, System ID 804594DEF1; UDI 01001952781183561123010021DX3SS2300005HL, System ID 757736TPO1; UDI 01001952781183561122050021DX3SS2200073HL, System ID 703494TEM; UDI 01001952781183561123030021DX3SS2300085HL, System ID 608930TEMPOXR; UDI 01001952781183561122050021DX3SS2200066HL, System ID 414649TEMPO; UDI 01001952781183561123040021DX3SS2300104HL, System ID 715538TEMP; UDI Not Available, System ID 304263DEF
Recalling Firm/
Manufacturer		 GE Hangwei Medical Systems, Co. LTD
West Area Bldg. 3, No.1 Yongchang North Road
1 Yongchangbeilu; Beijing Economic and Technological Development Area
Beijing China
For Additional Information Contact GE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		 GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
FDA Determined
Cause 2		 Process design
Action GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 11/07/2023 via FedEx. The notice explained the issue, hazard, and recommended the use of alternative device for patient exams until a service appointment can be scheduled to address the issue. Questions or concerns: Contact 1-800-467-1171 or local Service Representative
Quantity in Commerce 134 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE Hualun Medical Systems Co., Ltd
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