Shimadzu C-arm Table Recall Due to Interference Risk
Shimadzu Medical Systems is recalling 26 C-arm Tables because the C-arm may interfere with the table top under certain circumstances.
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 functional defect that poses a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Shimadzu Medical Systems is recalling 26 units of the Shimadzu C-arm Table, Catalog No. IVS-110. The recall involves 4 units distributed in the United States and 22 units distributed worldwide in countries including Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
The recall is being issued because the C-arm may interfere with the table top under certain circumstances. This interference could potentially affect the safe operation of the medical imaging equipment.
Healthcare facilities and users should contact Shimadzu Medical Systems for further instructions on how to address this issue. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
- Manufacturer
- Shimadzu Medical Systems
- Hazard
Distribution
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