CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging recalled

Ziehm Imaging is recalling Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging, distributed in 17 states. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

Quantity recalled12 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-2643-2016
FDA event ID: 74013
Recalling firm: Ziehm Imaging, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2016
FDA classified: 25 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

15 Apr 2016	Recall initiated by company
25 Aug 2016	Classified by FDA	+132 days
31 Aug 2016	Published in enforcement report	+6 days

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

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Where it was distributed

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

Arizona California Florida Georgia Illinois Massachusetts Michigan New Jersey Nevada New York Pennsylvania Puerto Rico Rhode Island Texas Utah Virginia Washington

Questions about this recall

Is Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging recalled?

Yes. Ziehm Imaging recalled Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging on 15 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2643-2016.

Why was it recalled?

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Which lots are affected?

Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

Where was it sold?

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

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 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
31 Aug 2016Device	CLASS II	Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states

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