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Recall Observatory FDA recall evidence

Device product

Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Z-0566-2014

November 21, 2013

Class II

Product summary

Firm
Ziehm Imaging Inc
Event
Event 66976
Status
Terminated
Classification
Class II
Quantity
1 device
Official record key
device-enforcement:Z-0566-2014

Official wording

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Code information: 90842

Distribution pattern: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.