The Recall Desk
HighFDA (Devices)·Z-2644-2016·Announced 2016-08-31

Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction

Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts 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 with a safety-critical warning malfunction (radiation timer) that could lead to unintended exposure, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ziehm Imaging Inc is recalling two units of the Ziehm Vision2 Mobile C-arm 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, no 5-minute timer dialogs or beeper sounds will occur until the unit is rebooted.

The affected devices have serial numbers 91760 and 91770. These units were distributed in the United States, including Puerto Rico, and to 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 to arrange for a repair or replacement of the affected devices to ensure proper warning systems are operational.

The recalled product

Product
Ziehm Vision2, 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: 91760 and 91770.

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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