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Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

Class I - Dangerous
🏥 Medical Devices Recalled: March 8, 2023 NeuroLogica Diagnostic Equipment Nationwide

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5637M3IR200008A 5637M3HR200005M 56F9M3HR800013V 56WPM3JT500006D 5637M3IR200002T 5631M3HR300004B 5637M3IR200007B 56F9M3HR800020W 5637M3HR200006T 5631M3IR200001X 5631M3IR200004B 5778M3HT800001X 5637M3IR200004X 5776M3IT800005W 5637M3IR300001P 5637M3RR400002Y 5631M3HR300002X 5630M3IR200001E 56L2M3IRB00002X 56KVM3HRB00004R 5631M3IR200003W 56KBM3IT100004T 56WPM3JT500007V 56L2M3HRA00005Z 56T5M3IRB00004K 56F9M3HR700010X 562GM3IR300007J 56F9M3HR800008R 56L2M3IRB00010R 5637M3HR300007D 5637M3HR300006B 56F9M3HR800010D 56F9M3HR700003W 5630M3HR300001Y 56F7M3IR900003X 5630M3HR300005N 56F9M3HR900003D 56WPM3JT600003R 56F9M3HR800030P 5631M3IR200012T 56F9M3HR900004P 56WPM3JT600001D 56L2M3HRA00009D 5631M3HR300003J 56L2M3IRB00001A 56WPM3JT500008X 56F9M3HR800009N 5637M3IR200005R 56F7M3IR900001E 56F9M3HR800021H 5637M3IR400005V 56L2M3HRA00004K 56F9M3HR800007M 56F9M3HR700006B 56F9M3HR800022E 562GM3IR300005K 5637M3HR200001L 56F9M3HR800028F 56KBM3HT600004Y 5776M3IT800007E 5637M3IR300005F 562GM3IR300003N 56KVM3HRB00005M 56L2M3IRB00004J 56WPM3JT500005W 56L2M3HRA00008P 5637M3HR200004F 56F9M3JR700002Z 56F9M3HR800004A 5631M3HR200002M UDI-DI: 08806088582412)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
NeuroLogica Corporation
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

Product Codes/Lot Numbers:

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 5637M3IR400001Y 5637M3IR400006P 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56L2M3IRB00004J 56WPM3JT500005W 56L2M3HRA00008P 5637M3HR200004F 56F9M3JR700002Z 56F9M3HR800004A 5631M3HR200002M UDI-DI: 08806088582412)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1414-2023

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