FDAClass IIJanuary 1, 2014

Ziehm Vista/Vista Plus C-Arm Interventional recall

Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Why was Ziehm Vista/Vista Plus C-Arm Interventional recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recalling firm
Ziehm Imaging Inc
Quantity
83 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.
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls