Samsung GU60A system- Digital X-ray Imaging Systems are intended for… — Class II medical device recall Z-3036-2017
Terminated recall by NeuroLogica Corporation, reported 2017-09-06, distributed nationwide. When performing the Stitching function on GU60A system, unintended area is exposed to radiation
| Recall number | Z-3036-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2017-05-24 |
| Classified | 2017-08-25 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2018-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 87 units |
| Serial numbers | 508UM3BF700001L, 508UM3BG100001T, 508UM3BG100002K, 50FFM3AG200001V, 50FFM3AG200002K, 50FFM3AG200003P, 50FFM3AG200004E, 50FFM3AG200005J, 50FFM3AG300001X, 50FFM3AG700001Y, 50FFM3AG700002L, 50FFM3AG800004K, 50FFM3BG600001A, 50FFM3BG600002V, 50FFM3BG600003E, 50FFM3CG700001P, 50FFM3CG700002B, 50FFM3CG700003M, 50FFM3CG700004E, 50FFM3CG700005A, 50FFM3CG700006T, 50FFM3CG700007J, 50FFM3CG700008N, S03PM3ADA00001T, S03PM3ADC00001H and 33 more |
Product
Samsung GU60A system- Digital X-ray Imaging Systems are 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
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
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-3036-2017. 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.