Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The… — Class II medical device recall Z-1691-2019
Terminated recall by NeuroLogica Corporation, reported 2019-06-05, distributed nationwide. Potential issue related to the operation of the safety latch within the column that supports the arm due to a
| Recall number | Z-1691-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2019-05-06 |
| Classified | 2019-05-30 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 288 systems |
| Serial numbers | 513YM3IJA00001X, 513YM3IK100001A, 513YM3IK100002D, 513YM3IK100003N, 513YM3IK400001W, 513YM3IK400002A, 513YM3IK500001K, 513YM3IK500002R, 513YM3IK500003Z, 513YM3IK500004H, 513YM3IK500005Y, 5143M3DHB00001M, 5143M3GK500001H, 5143M3GK500002Y, 5143M3GK500003J, 5143M3GK500004A, 5143M3GK500005M, 5143M3GK500006P, 5143M3GK500007W, 5143M3GK500008D, 5143M3HJ500001Y, 5143M3HJ500002J, 5143M3HJ500003A, 5143M3HJ500004M, 5143M3HJ500005P and 263 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1691-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.