Device product
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Z-0566-2014
Product summary
- 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
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.