Recall Z-1893-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm Imaging Inc
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
| Date | Feb 23, 2017 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling design |
| 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 |
| Quantity | US - 2 systems |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161976 | Ziehm Solo FD Ziehm Imaging GmbH, Oct 6, 2016 |