Canon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.
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 structural defect in a medical device where components may become loose, posing a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography/fluoroscopy systems (Models INFX-8000C, INFX-8000F, and INFX-8000V). These devices are used in diagnostic and interventional angiography configurations for blood vessels in the heart, brain, abdomen, and lower extremities.
The recall is due to a defect where the fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose. This issue affects 10 systems distributed nationwide in California, Georgia, Minnesota, North Carolina, Nevada, Pennsylvania, Ohio, and Texas.
Healthcare facilities should contact Canon Medical System, USA, INC. for instructions on how to address the defect. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the…
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 10
Distribution
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