Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction
Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users 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 where a safety warning system (radiation timer) may fail, creating a risk of harm (excessive radiation exposure) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ziehm Imaging Inc is recalling 31 units of the Ziehm Vision RFD 3D 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, the 5-minute timer dialogs and beeper will not activate until the unit is rebooted.
The affected devices 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. The specific serial numbers for the recalled units are 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.
Healthcare facilities and users should check their device serial numbers against the list provided by the manufacturer. If a device is affected, users should contact Ziehm Imaging Inc for instructions on how to resolve the issue, which may involve a reboot or other corrective action to ensure the warning systems function correctly.
The recalled product
- Product
- Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Affected units
- 31
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 (20)
- Serial #'s 20628
- 20657
- 20658
- 20659
- 20660
- 20671
- 20672
- 20678
- 20679
- 20680
- 20681
- 20682
- 20683
- 20684
- 20685
- 20686
- 20687
- 20712
- 10713
- 20714
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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