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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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
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