Z-0568-2014 Class II Terminated
FDA device recall Z-0568-2014 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: 27 devices.
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
- 27 devices
Product Description
Ziehm Vision RFD 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
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