Ziehm Imaging solo FD Mobile Fluoroscopic C-arm — Class II medical device recall Z-1893-2017
Terminated recall by Ziehm Imaging Inc, reported 2017-05-24, distributed in CA, FL. During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the
| Recall number | Z-1893-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Ziehm Imaging Inc, Orlando, FL, United States |
| Recall initiated | 2017-02-23 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2019-12-11 |
| Distributed | CA, FL |
| Quantity | 2 systems |
| Reason classes | labeling |
Product
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Reason for recall
During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
Machine access
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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.