Recall Z-0565-2014 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm Imaging Inc
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
| Date | Dec 24, 2013 (initiated Nov 21, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device instal |
| Quantity | 54 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073346 | ZIEHM VISION 2 Ziehm Imaging, Inc., Mar 21, 2008 |