Canon Medical System INFX-8000C C-Arm Recall for X-Ray Field Shift
Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.
What this means for you
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 is classified as FDA Class II, and the hazard involves a potential misalignment of the x-ray beam which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Canon Medical System, USA, INC. is recalling 272 units of the System INFX-8000C (Models CAS-880A and CAS-830B) nationwide. The recall was initiated 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 issue could result in the x-ray beam not aligning precisely with the visual feedback provided to the operator on the screen. The recall affects 272 units distributed nationwide.
Healthcare facilities and users of these systems should contact Canon Medical System for further instructions on how to address this defect.
The recalled product
- Product
- System INFX-8000C
- Manufacturer
- Canon Medical System, USA, INC.
- 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.
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