Z-0566-2014 Class II Terminated
FDA device recall Z-0566-2014 was initiated by Ziehm Imaging Inc on November 21, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 23, 2014). Affected quantity: 1 device.
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