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Open, Classified

System INFX-8000V

FDA Recall Z-1174-2021 · Posted None

Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeOWB
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.

K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation · 2017-06-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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