Ziehm Imaging Inc: Medical Device Recall in 2016 - (Recall #: Z-2644-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2016.
Data Source: FDA.
Product Description:
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Product Classification:
Class II
Date Initiated: April 15, 2016
Date Posted: August 31, 2016
Recall Number: Z-2644-2016
Event ID: 74013
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.
Status: Terminated
Product Quantity: 2 devices
Code Information:
Serial #'s: 91760 and 91770.
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.
Voluntary or Mandated:
Voluntary: Firm initiated