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Recall Observatory FDA recall evidence

Device product

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

Z-2639-2016

April 15, 2016

Class II

Product summary

Firm
Ziehm Imaging Inc
Event
Event 74013
Status
Terminated
Classification
Class II
Quantity
31 devices
Official record key
device-enforcement:Z-2639-2016

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.