Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction
Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its 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 feature malfunction (radiation warning timer) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ziehm Imaging Inc is recalling one Ziehm Vision R 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 device has serial number 10841. It was 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 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 R, Mobile C-arm for Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Affected units
- 1
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 # 10841.
Distribution
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.
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