System INFX-8000F
FDA Recall Z-1176-2021 · Posted None
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeMQB
Date Initiated2021-02-05
Product Quantity272 in total
Reason for Recall
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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