FDA Device recall Z-1414-2023
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System by Neurologica, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1414-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-08 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neurologica |
| Distribution | US |
Product
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Reason
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
Identifiers
| code_info | UDI-DI: 08806088582412 GM85 systems S/N: 5143M3JK100005D 52VUM3IK800002X 52VYM3HMA00001B 52WAM3IM500003W 55Y9M3IN100001…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1414-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.