FDAFDA · Food and drugs·Recall number Z-1893-2017
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Published May 24, 2017 · Recall initiated: February 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Ziehm Imaging Inc
- Distributor
- 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.
- Lot
- S/N 52199, 52108
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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