Z-0565-2014 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
- 54 devices
Product Description
Ziehm Vision(2) 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
9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815