FDA Device recall Z-1691-2019
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating rad…
- FDA Device
- Class II
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class II recall of Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating rad… by Neurologica, citing potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1691-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-06 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Neurologica |
| Distribution | US |
Product
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Reason
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Identifiers
| code_info | Serial Numbers: 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 5143M3HJ500001Y 5143M3IK400005T 513YM3IK100001A…Serial Numbers: 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 5143M3HJ500001Y 5143M3IK400005T 513YM3IK100001A 5143M3IJ600014H 5143M3JK400005Y 5143M3IJ400007P 5143M3HK400003P 52VUM3IKA00008M 513YM3IJA00001X 5143M3JJ400007E 5143M3JJ400006K 52VUM3HK800003X 52VUM3IKA00009W 5143M3JJ300001K 5143M3HJ600003K 5143M3JJ300002X 5143M3JJ300003J 5143M3IJ800008L 5143M3IK400003Z 5149M3IK400001H 5149M3IK400002K 5143M3HK400002V 52VUM3IKA00016E 5143M3HK300004E 514GM3HK100005L 5143M3JK100012J 5143M3IJC00001Y 5143M3JK100003Z 5143M3JK100002B 5143M3HK600006E 5143M3IK400002J 514GM3HK100002R 5143M3HK300007N 52VUM3HK800002F 5143M3HK300010P 52VUM3IK800004K 5143M3IJ100005R 5143M3IK300002J 5143M3HJA00002K 514GM3IK400001L 5143M3JJ200011L 5143M3JJ300012N 5143M3IJ600007N 5143M3IHC00003Y 5143M3IHC00004N 5143M3IHC00015L 5143M3IHC00013X 5143M3DHB00001M 5143M3IHC00014H 5143M3RJ100002V 5143M3JJ200004Y 5143M3JJ200005X 5143M3JK400008N 5143M3JK100015B 5143M3HJA00006 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2019%22
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