FDA Medical Device Recalls (openFDA)
Canon Medical System, USA, INC.: System INFX-8000C
- Recall number
- Z-1175-2021
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- System INFX-8000C
- Status
- Open, Classified
- Initiated
- 2021-02-05
- Posted
- not on file
- Terminated
- not on file
- Reason
- The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
- Root cause
- Software design
- 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.
- Quantity
- 272 in total
- Distribution
- Nationwide
- Lot, serial or model codes
- Model: CAS-880A, CAS-830B
- 510(k) numbers
- ["K152697"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28