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

Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System recalled

Ziehm Imaging is recalling Ziehm Vision R 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 codes10016 10070 10135 10153 10235 10485 10026 10071 10092 10154 10260 10486 10028 10072 10093 10155 10265 10488 10030 10073 10094 10156 10266 10489 10031 10074 10109 10162 10396 10490 10038 10075 10111 10181 10431 10491 10042 10076 10117 10192 10434 10510 10045 10078 10118 10196 10435 10519 10046 10080 10119 10197 10436 10520 10048 10081 10121 10198 10443 10521 10049 10082 10122 10202 10457 10524 10053 10083 10123 10207 10458 10525 10054 10086 10124 10209 10459 10528 10056 10087 10125 10214 10460 10066 10088 10126 10215 10462 10067 10089 10127 10216 10472 10068 10090 10131 10223 10476 10069 10091 10134 10233 10484

Quantity recalled103 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-0567-2014
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 R 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 R C-Arm Interventional Fluoroscopic X-Ray System recalled?

Yes. Ziehm Imaging recalled Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System on 21 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0567-2014.

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?

10016 10070 10135 10153 10235 10485 10026 10071 10092 10154 10260 10486 10028 10072 10093 10155 10265 10488 10030 10073 10094 10156 10266 10489 10031 10074 10109 10162 10396 10490 10038 10075 10111 10181 10431 10491 10042 10076 10117 10192 10434 10510 10045 10078 10118 10196 10435 10519 10046 10080 10119 10197 10436 10520 10048 10081 10121 10198 10443 10521 10049 10082 10122 10202 10457 10524 10053 10083 10123 10207 10458 10525 10054 10086 10124 10209 10459 10528 10056 10087 10125 10214 10460 10066 10088 10126 10215 10462 10067 10089 10127 10216 10472 10068 10090 10131 10223 10476 10069 10091 10134 10233 10484

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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