The Recall Desk
HighFDA (Devices)·Z-2641-2016·Announced 2016-08-31

Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction

Ziehm Imaging Inc is recalling two Ziehm Vision RFD mobile C-arms because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a safety warning system (radiation timer) may fail, creating a risk of harm (excessive radiation exposure) even though no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Ziehm Imaging Inc is recalling two units of the Ziehm Vision RFD, a mobile C-arm used for mobile fluoroscopic imaging. The recall is due to a malfunction in the radiation-warning timer and the 3D-specific interval warning. When this defect occurs, the 5-minute timer dialogs and beeper will not activate until the unit is rebooted.

The affected devices have serial numbers 20719 and 20721. These units were distributed in the United States, including Puerto Rico, and in the states of Florida, Georgia, Virginia, Massachusetts, Maine, Michigan, New York, New Jersey, Pennsylvania, Rhode Island, Illinois, Texas, Arizona, California, Nevada, Utah, and Washington.

Healthcare facilities should contact Ziehm Imaging Inc for instructions on how to address the malfunction. Users should be aware that the lack of timer alerts may affect the monitoring of radiation exposure intervals until the device is rebooted.

The recalled product

Product
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Manufacturer
Ziehm Imaging Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial #'s 20719 and 20721.

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 6 recalled by Ziehm Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Ziehm Imaging Inc

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Same hazard · radiation exposure

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