Device product
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Z-1893-2017
Product summary
- Event
- Event 77030
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 2 systems
- Official record key
device-enforcement:Z-1893-2017
Official wording
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
Code information: S/N 52199, 52108
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.
Derived failure modes
-
Unknown
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