Canon Alphenix Interventional Angiography System Recalled for Software Error
Canon Medical System is recalling three Alphenix Interventional Angiography Systems due to a software issue that may cause internal errors during specific imaging tasks.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a software issue that may cause internal errors during specific imaging tasks. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Canon Medical System, USA, INC. is recalling three units of the ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM (REF: INFX-8000F). The recall is due to a software issue that may cause the X-ray interventional system to experience an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use.
The affected units were distributed nationwide in the United States, specifically in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oregon, and Texas. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities should contact Canon Medical System for instructions on how to address the software issue. Consumers are not directly affected as this is a medical device used in clinical settings.
The recalled product
- Product
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- Affected units
- 3
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)
- DI-04987670100208/
Distribution
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