Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
FDA Recall Z-1893-2017 · Posted None
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Recalling FirmZiehm Imaging Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-02-23
Date Terminated2019-12-11
Product QuantityUS - 2 systems
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
Firm Action
Ziehm Imaging will bring defect into compliance:
Customer Precautions: Therefore, as there is no identifiable risk to patients, users or third parties, the manufacturer Ziehm Imaging GmbH advises customers they may continue to operate the affected device until the labeling materials can be remediated.
Please alert all staff members working with the device to this notification.
Remedy:
1. You will contact customers and initiate the actions to correct the failure to comply issues.
2. You will affix the identification labels to the collimator and x-ray control panel.
3. You will replace the existing user manual with one that reflects the reference images of the labels with manufacturer date.
If there are any questions or concerns regarding this product safety issue, please do not hesitate to contact our National Service Team for further information at Ziehm Imaging, Inc. Toll-Free: (866) 949-4346, Fax: (866) 839-7893 or E- Mail: [email protected]
Root Cause
Labeling design
Distribution Pattern
US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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