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U.S. Department of Health and Human Services

Class 2 Device Recall Samsung GM85 Digital Xray Imaging System

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 Class 2 Device Recall Samsung GM85 Digital Xray Imaging Systemsee related information
Date Initiated by FirmMarch 08, 2023
Date PostedApril 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1414-2023
Recall Event ID 91959
510(K)NumberK222353 
Product Classification System, x-ray, mobile - Product Code IZL
ProductSamsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Code Information UDI-DI: 08806088582412 GM85 systems S/N: 5143M3JK100005D 52VUM3IK800002X 52VYM3HMA00001B 52WAM3IM500003W 55Y9M3IN100001W 562GM3HN400002J 562GM3IN300005E 562GM3IR300002Z 562GM3JR200005D 562GM3JR200006F 562GM3JR200007M 562GM3JR300001B 5637M3HN200004T 56T5M3IRB00001R 5143M3HK600001D 5143M3IK400009H 5143M3IK600001Y 5143M3IK600003N 5143M3IK600004K 5143M3JK500002P 5143M3JK500003W 5143M3JK500005V 5143M3JK500007L 5637M3JN400002A 52VUM3HM600019F 52VUM3HM700001X 52VUM3HM700002Z 52VUM3HM700003V 52VUM3HM700004R 52VUM3HM700005D 52VUM3IKA00018R 52VUM3IM700001A 52VUM3IM700003J 52VYM3IM500002F 52VYM3IM500007Y 52VYM3IM500009A 52VYM3IM500012T 5631M3RNC00007W 5637M3RR400005N 5143M3DHB00001M 5143M3HJ500005P 5143M3HJ500006W 5143M3HJ900005J 5143M3IJ600006W 5143M3JJ400002X 5143M3IJ800001B 5143M3IJ800002V 5143M3IJ800003J 5143M3IJ800004F 5143M3IJ800005X 5143M3JJ700005W 52VUM3HM600005L 52VUM3HM600006F 52VUM3HM600008W 52VUM3HM600009N 52VUM3HM600010V 52VUM3HM600017P 52VUM3IM600005M 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FEI Number 3004938766
Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
For Additional Information ContactSAME
978-564-8500
Manufacturer Reason
for Recall		Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
FDA Determined
Cause 2		Device Design
Action NeuroLogica (Importer)for Samsung Electronics GM85 digital x-ray system issued Urgent Medical Device Correction letter issued 3/8/23 via email. Letter states reason for recall, health risk and action to take: Please identify the system label and confirm whether or not your device is one of those affected by this FSN. The list of affected serial numbers is provided in the Appendix. Samsung Electronics will undertake the voluntary corrective action considering the possibility of potential bodily harm due to the fall of the arm. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field will be completed by September 2023. Users may continue to use the GM85 system. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action
Quantity in Commerce935 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZL
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