FDAFDA · Food and drugs·Recall number Z-2642-2016
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Published August 31, 2016 · Recall initiated: April 15, 2016
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
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ziehm Imaging Inc
- Distributor
- US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
- Lot
- Serial # 10841.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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