Samsung GM60A-40S Intended for use in generating radiographic images… — Class II medical device recall Z-0263-2016
Terminated recall by NeuroLogica Corporation, reported 2015-11-18, distributed in MA, MO, NC, OH. When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper contr
| Recall number | Z-0263-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-11-10 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2017-01-19 |
| Distributed | MA, MO, NC, OH |
| Quantity | 7 devices |
| Serial numbers | 50EAM9BG200001A, 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200004X, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F |
Product
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Reason for recall
When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.
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-0263-2016. 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.