Z-1176-2021Class II

System INFX-8000F

Name: Z-1176-2021 System INFX-8000F
Creator: Canon Medical System, USA, INC.
Published: 2021-02-05
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2021-02-05 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of System INFX-8000F on 2021-02-05. FDA classified it as Class II and gives the reason as "The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1176-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-05
Posted: 2021-03-09
Recalling firm: Canon Medical Systems USA, Inc.
Product: System INFX-8000F
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: software
FDA 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 in commerce: 272 in total
Distribution: Nationwide
Product codes and lots: Model: CAS-880A, CAS-830B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1176-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1174-2021	Class II	Ongoing	FDA Mandated	2021-03-17	2021-03-09
Z-1175-2021	Class II	Ongoing	FDA Mandated	2021-03-17	2021-03-09
Z-1176-2021	Class II	Ongoing	FDA Mandated	2021-03-17	2021-03-09

Product code MQB

K081624Class IIInfx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C / cleared 2008-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)