Class II — Ziehm Imaging Inc
| Recalling firm | ZIEHM IMAGING GMBH |
|---|---|
| Registered facility | ZIEHM IMAGING GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging |
| Quantity | 31 devices |
| Distribution | US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA. |
| Initiated | 2016-04-15 |
| Classified | 2016-08-25 |
| Terminated | 2019-07-18 |
| Recall number | Z-2639-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ziehm Imaging Inc (Z-2639-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74013/
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