Skip to content
Recall Observatory FDA recall evidence

Device product

Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Z-0568-2014

November 21, 2013

Class II

Product summary

Firm
Ziehm Imaging Inc
Event
Event 66976
Status
Terminated
Classification
Class II
Quantity
27 devices
Official record key
device-enforcement:Z-0568-2014

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: 20006 20025 20142 20185 20216 20231 20015 20026 20151 20186 20217 20236 20016 20027 20153 20189 20225 20018 20031 20166 20198 20227 20019 20139 20184 20199 20228

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.