NeuroLogica Corporation: Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

Hazard

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

Details from the source

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 Distribution: US Nationwide distribution. Quantity: 935 units Lot/code info: 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 5637M3RR400006V 52VUM3IM600003E 5631M3RNC00004B 5637M3HR300004X 56F9M3HR800026V 56KBM3JT600001D 5143M3IJC00001Y 5143M3JK100002B 5143M3JK100003Z 52VUM3JM400002T 5637M3INA00005L 52VYM3IM500003K 52VYM3IM500006H 52VYM3IM500008J 52VYM3IM500010L 5143M3IJ300002Y 5143M3IJ300006N 5637M3HR400002M 5637M3IR400004N 52VUM3HM400005Y 52VUM3HM400009V 52VUM3HM400010W 52VUM3JM400006H 52VUM3JM400003X 52VYM3IM500001B 52VYM3IM500005Z 55GFM3HM500002P 52VUM3HM600016H 52VUM3IM600001A 5637M3INA00018L 56L2M3HRA00007A 514

UPC codes

08806088582412

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.