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U.S. Department of Health and Human Services

Class 2 Device Recall Equipment

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  Class 2 Device Recall Equipment see related information
Date Initiated by Firm November 08, 2023
Date Posted January 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-0761-2024
Recall Event ID 93567
Product Classification Lamp, surgical - Product Code FTD
Product Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X
Code Information All systems affected UDI-DI: 03700712400583 03700712400606 03700712400590 3700712401252 3700712401269 3700712414184 3700712411855 3700712411862 3700712420208 3700712415778 3700712417123 3700712411916 3700712411923 3700712415822 3700712414177 3700712417154 3700712417161 3700712411879 3700712411886 3700712414160 3700712417130 3700712417147 3700712411893 3700712411909 3700712401092 3700712401108 03700712405946 3700712416829 3700712416805 3700712416812 3700712421076 3700712421083 3700712421090 3700712421106 3700712417253 3700712417260 3700712417277 3700712417239 3700712417246 03700712417031 3700712420130 03700712417048 3700712416072 3700712416997 3700712417000 3700712416126 3700712416119 3700712420147 3700712416065 3700712417017 3700712417024 3700712416096 3700712416102 3700712414306 3700712414283 3700712414290 3700712400972 3700712400989 3700712400996 3700712401009 03700712401016 3700712401023 3700712401030 3700712401047 03700712401078 03700712401085 3700712401191 3700712401207 03700712417178 3700712401276 3700712419349 3700712401283 3700712400057 3700712401221 03700712405915 03700712405908 3700712400132 3700712401245 03700712406073 03700712406059 3700712401054 3700712420178 3700712401061 3700712406042 3700712422240 3700712422257 3700712422264 3700712421427 3700712422271 3700712422288 3700712421403 3700712422295 3700712422301 3700712422318 3700712422325 3700712422332 3700712422349 3700712422356 3700712422363 3700712422370 3700712421441 3700712422387 3700712422394 3700712421465 3700712422400 3700712422417 3700712421496 3700712422424 3700712421472 3700712422431 3700712422448 3700712421489 3700712422455 3700712422462 3700712422479 3700712421410 3700712422486 3700712422493 3700712422509 3700712421458 3700712421434 3700712422516 3700712422523 3700712422530 3700712422547 3700712422554 3700712422561 3700712422578 3700712422585 3700712422592
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information Contact Jessica Minaya
973-709-7634
Manufacturer Reason
for Recall		 A potential for a light system to fall in the operating room.
FDA Determined
Cause 2		 Equipment maintenance
Action An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and other replacements: Regarding: - the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws - the brake screws - the safety segments - the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued. The instruction is available on a dedicated space on the web portal https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/, and provided upon request by emailing MSA808092.sw@getinge.com Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to or-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Maquet SAS / Getinge: As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin
Quantity in Commerce 236793 units in total
Distribution US Nationwide. Global 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.
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