System INFX-8000V
Recall
- Recall Number
- Z-1174-2021
- Event Number
- 87419
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- February 5, 2021
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
System INFX-8000V
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
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.
Nationwide
272 in total