Ziehm Vision2 — Class II medical device recall Z-2644-2016
Terminated recall by Ziehm Imaging Inc, reported 2016-08-31, distributed in AZ, CA, FL, GA, IL, MA, ME, MI…. Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or
| Recall number | Z-2644-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ziehm Imaging Inc, Orlando, FL, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2016-08-25 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2019-07-18 |
| Distributed | AZ, CA, FL, GA, IL, MA, ME, MI, NJ, NV, NY, PA, PR, RI, TX, UT, VA, WA |
| Quantity | 2 devices |
| Reason classes | device malfunction |
| Serial numbers | 91760, 91770 |
Product
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Reason for recall
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.
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-2644-2016. 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.