Radiographic imaging system may exceed radiation dose limits in biplane mode
Canon Medical's Alphenix i imaging systems may deliver radiation dose rates exceeding acceptable limits during biplane fluoroscopic procedures. Sixteen systems nationwide with software versions 8.0, 9.0, or 9.2 and TFP 1200C detector are affected.
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: FDA Class II device recall involving potential for excessive radiation dose during a specific imaging procedure. No illnesses or injuries have been reported. The hazard is theoretical and unconfirmed, consistent with the rubric for High severity.
Plain-English summary
Canon Medical System, USA, INC. is recalling the Alphenix i (model INFX-8000V) radiographic and fluoroscopic imaging system used for diagnostic imaging and interventional procedures. Sixteen systems with nationwide distribution are affected.
The affected systems use software versions 8.0, 9.0, or 9.2 combined with the TFP 1200C flat panel detector. These systems may deliver fluoroscopic dose rates that exceed the conforming value during biplane fluoroscopy, which involves simultaneous imaging from two perpendicular angles.
Facilities operating affected systems should contact Canon Medical System, USA, INC. to verify if their equipment is included in this recall and obtain guidance on remediation.
The recalled product
- Product
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- Affected units
- 16
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 (2)
- Model: Alphenix i with software version 8.0
- 9.0 or 9.2 and the TFP 1200C FPD.
Distribution
Distributed nationwide across the United States.
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