FDA Device recall Z-0263-2016
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy by Neurologica, citing 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 stopp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0263-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Neurologica |
| Distribution | MA, MO, NC, OH |
Product
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Reason
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.
Identifiers
| code_info | Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0263-2016%22
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