• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recall Number Z-0562-2014
Classification Class II
Code Info 5652 5704 5758 5772 5792 5840 5653 5714 5759 5773 5796 5844 5654 5715 5760 5774 5798 5846 5655 5716 5761 5775 5805 5847 5656 5717 5762 5776 5809 5854 5695 5718 5763 5777 5810 5855 5696 5720 5764 5779 5814 5860 5697 5721 5765 5780 5816 5861 5698 5722 5766 5781 5823 5862 5699 5723 5767 5782 5828 5863 5700 5749 5768 5783 5830 5864 5701 5750 5769 5784 5833 5865 5702 5751 5770 5785 5838 5866 5703 5755 5771 5787 5839
Product Distributed Qty 83 devices
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.

Event Detail

Event Id 66976
Product Type Devices
Status Ongoing
Recalling Firm Ziehm Imaging Inc
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-21
Initial Firm Notification of Consignee or Public Letter
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.
-
-