CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report

Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic recalled

Ziehm Imaging is recalling Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System, distributed nationwide in the US. The recall was initiated on 21 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes5652 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

Quantity recalled83 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0562-2014
FDA event ID: 66976
Recalling firm: Ziehm Imaging, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2013
FDA classified: 24 Dec 2013
Reported: 1 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

21 Nov 2013	Recall initiated by company
24 Dec 2013	Classified by FDA	+33 days
1 Jan 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan

Questions about this recall

Is Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System recalled?

Yes. Ziehm Imaging recalled Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System on 21 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0562-2014.

Why was it 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.

Which lots 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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ziehm Imaging

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Reported	Class	Recall	Company	Reason	Where
24 May 2017Device	CLASS II	solo FD Mobile Fluoroscopic C-arm recalled by Ziehm Imaging	Ziehm Imaging	Processing Deviation	CA, FL
31 Aug 2016Device	CLASS II	Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states

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