Canon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
Canon Medical System is recalling one Alphenix INFX-8000C/B5 unit in Idaho due to a risk of tabletop shifting that could cause patient misalignment.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a mechanical defect that may cause patient misalignment and motion errors. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Canon Medical System, USA, INC. is recalling one unit of the Alphenix INFX-8000C/B5 medical device. The recall is limited to the state of Idaho. The specific unit is identified by serial number B5F2532011 and UDI 4987670100192.
The recall is being issued because loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift. This shift can result in positional, imaging, or patient misalignment and a longitudinal motion error.
The source text does not report any illnesses, injuries, or deaths associated with this defect. The source does not provide specific instructions for consumers or healthcare providers on how to address the issue.
The recalled product
- Product
- Alphenix INFX-8000C/B5
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 1
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)
- Serial no. B5F2532011/UDI: 4987670100192
Distribution
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