Z-2641-2016 Class II Terminated

Recalled by Ziehm Imaging Inc — Orlando, FL

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
2 devices

Product Description

Ziehm Vision RFD, 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 20719 and 20721.