Z-1893-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- February 23, 2017
- Termination Date
- December 11, 2019
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 2 systems
Product Description
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
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.
Code Information
S/N 52199, 52108