FDAFDA · Food and drugs·Recall number Z-2639-2016
Ziehm Vision RFD 3D 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 #'s 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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