Z-0566-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2014
- Initiation Date
- November 21, 2013
- Termination Date
- June 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 device
Product Description
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Reason for Recall
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.
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.
Code Information
90842