Ziehm Imaging Inc: Medical Device Recall in 2016 - (Recall #: Z-2639-2016)

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 Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: August 31, 2016

Recall Number: Z-2639-2016

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: 31 devices

Code Information:

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.

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