Z-2643-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- April 15, 2016
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product Description
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.