Canon Medical System, USA, INC. System INFX-8000F Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
System INFX-8000F
Brand
Canon Medical System, USA, INC.
Lot Codes / Batch Numbers
Model: CAS-880A, CAS-830B
Products Sold
Model: CAS-880A, CAS-830B
Canon Medical System, USA, INC. is recalling System INFX-8000F due to The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Recommended Action
Per FDA guidance
A customer notification letter was sent to affected customers, which includes instructions to (1) manually operate the diaphragm blades of the collimator to adjust the X-ray irradiation field to the appropriate irradiation field position, (2) when adjusting the diaphragm blades, you can find this problem by checking the position of the diaphragm blades with respect to the image receiving surface displayed on the screen, (3) contact their Canon Service representative if they find any abnormalities regarding this issue in the operation of the Infinix System and if they have any questions. And includes a statement that Canon Medical Solutions USA will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Service, the details of which will be included in a subsequent communication to you or Canon field engineer site visit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026