Z-1154-2024Class II

The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an...

Name: Z-1154-2024 The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an...
Creator: Canon Medical System, USA, INC.
Published: 2023-11-15
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2023-11-15 / Open, Classified / root cause: manufacturing process

FDA source

Canon Medical System, USA, INC. began a recall of The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm... on 2023-11-15. FDA classified it as Class II and gives the reason as "VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1154-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-15
Posted: 2024-02-16
Recalling firm: Canon Medical Systems USA, Inc.
Product: The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Root cause tag: manufacturing process
FDA root cause: Component change control
Action: On 11/15/23 correction notices were distributed to customers who were asked to do the following: 1) Should this issue occur please attempt to restart the system and contact your service representative. 2) A recalling firm representative will contact you to schedule a time to replace the flat panel detector on the console. The parts required to address the defect are expected to be available no earlier that December 2023. 3) Complete and return the customer reply form via email to [email protected] For questions, please contact our InTouch team at [email protected] or 800-421-1968, or 800.521.1968.
Quantity in commerce: 1
Distribution: US: CA, LA
Product codes and lots: UDI-DI: 04987670100192, Serial Number: B1E22X2005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1154-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1154-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1155-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code OWB

K210900Class IIAlphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation / cleared 2021-04-12

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)