Home / Recalls / Ziehm Imaging Inc / Z-0562-2014

Z-0562-2014 Class II Terminated

Recalled by Ziehm Imaging Inc — Orlando, FL

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
83 devices

Product Description

Ziehm Vista/Vista Plus 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

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

Other recalls by Ziehm Imaging Inc

  • Z-1893-2017 Class II — Ziehm Imaging solo FD Mobile Fluoroscopic C-arm (February 23, 2017)
  • Z-2644-2016 Class II — Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-2642-2016 Class II — Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-2641-2016 Class II — Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-2640-2016 Class II — Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-2639-2016 Class II — Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-2643-2016 Class II — Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging (April 15, 2016)
  • Z-0565-2014 Class II — Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoro (November 21, 2013)
  • Z-0563-2014 Class II — Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopi (November 21, 2013)
  • Z-0566-2014 Class II — Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu (November 21, 2013)