Z-1289-2022Class II

System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF...

Name: Z-1289-2022 System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF...
Creator: Canon Medical System, USA, INC.
Published: 2022-05-03
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2022-05-03 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW on 2022-05-03. FDA classified it as Class II and gives the reason as "CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated". 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-1289-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-03
Posted: 2022-06-24
Recalling firm: Canon Medical Systems USA, Inc.
Product: System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
Root cause tag: software
FDA root cause: Software design
Action: On or about 04/20/2022, Canon Medical Systems USA, Inc sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customer of a potential issue with your ALPHENIX System when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error "H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patient needing to be moved to another system for a repeat scan, which could cause a delay in diagnosis or decrease comfort for the patient. Customers are being informed that the Recalling Firm has developed a software update that will be installed by a representative of Canon Medical Systems USA that should correct the issue/situation. Prior to the install of the software update, the Urgent customer letter provides a Error resetting (workaround) as follows: 1. Hold down the Anatomical angle control selection button and the Override button on the tableside console or the satellite console (option) simultaneously for at least 1 second. 2. Repeat a second time. This should resolve the error on the CT system. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or email [email protected] or the Canon Service Representative at 800-521-1968
Quantity in commerce: 6 systems
Distribution: U.S.: CA, CO, FL, NY, and WY O.U.S.: None
Product codes and lots: UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1289-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1289-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-24

Product code OWB

K181804Class IIAlphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation / cleared 2018-08-02

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)