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

Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System recalled

Ziehm Imaging is recalling Ziehm Vision(2) 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 codes9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815

Quantity recalled54 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-0565-2014
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 Vision(2) 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 Vision(2) C-Arm Interventional Fluoroscopic X-Ray System recalled?

Yes. Ziehm Imaging recalled Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System on 21 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0565-2014.

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?

9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815

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

All 14

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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