FDA Device recall Z-2643-2016
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging by Ziehm Imaging, citing malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2643-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ziehm Imaging |
| Distribution | AZ, CA, FL, GA, IL, MA, ME, MI, NJ, NV, NY, PA, PR, RI, TX, UT, VA, WA |
Product
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
Reason
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Identifiers
| code_info | Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2643-2016%22
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