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Recall Observatory FDA recall evidence

Device product

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2643-2016

April 15, 2016

Class II

Product summary

Firm
Ziehm Imaging Inc
Event
Event 74013
Status
Terminated
Classification
Class II
Quantity
12 devices
Official record key
device-enforcement:Z-2643-2016

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: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

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.