Canon Medical System INFX-8000F X-ray Systems Recalled for Field Shift
Canon Medical System is recalling 272 INFX-8000F systems because the x-ray field may shift at certain angles.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Canon Medical System, USA, INC. is recalling 272 units of the System INFX-8000F, a medical device used for x-ray imaging. The recall covers models CAS-880A and CAS-830B distributed nationwide.
The recall is being issued because the x-ray irradiation field may shift with respect to the image receiving surface displayed on the screen at some C-arm angles. This potential misalignment could affect the accuracy of the imaging.
Healthcare facilities and users of these devices should contact Canon Medical System for further instructions on how to address the issue. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- System INFX-8000F
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- Affected units
- 272
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: CAS-880A
- CAS-830B
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Canon Medical System, USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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