Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction
Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific 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 is classified as FDA Class II and involves a malfunction in safety warning systems for radiation exposure, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Ziehm Imaging Inc is recalling 12 units of the Ziehm Solo 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. Specifically, the 5-minute timer dialogs and beeper will not occur 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 51837, 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975, and 51977.
Healthcare facilities and users should contact Ziehm Imaging Inc for further instructions on how to address the malfunction. The recall is classified as Class II by the FDA, indicating that the malfunction may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Affected units
- 12
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 (10)
- Serial #'s: 51837. 51838
- 51900
- 51901
- 51902
- 51903
- 51953
- 51955
- 51973
- 51974
- 51975 and 51977.
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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