Z-3014-2026Class II

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used...

Name: Z-3014-2026 Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used...
Creator: Canon Medical System, USA, INC.
Published: 2026-08-04
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2026-08-04 / Open, Classified / root cause: manufacturing process

FDA source

Canon Medical System, USA, INC. began a recall of Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography... on 2026-08-04. FDA classified it as Class II and gives the reason as "Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose". 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-3014-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-04
Posted: 2026-08-25
Recalling firm: Canon Medical Systems USA, Inc.
Product: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/04/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was sent via email informing customers that, It has been found there is a possibility that the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Indications that the screws have loosened are abnormal noises and sensor errors from the ceiling mounted C-arm. Customers are instructed to: Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. A representative of Canon Medical Systems USA will contact customers to schedule a time to check for the tightening and proper attachment of the fixing screws to correct this issue your system(s). For Questions - contact your service representative contact the InTouch team at [email protected].
Quantity in commerce: 10 systems
Distribution: U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
Product codes and lots: Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004 Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002 Model Number: INFX-8000V/B9 UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001 Model Number: INFX-8000V/ST UDI code: Pending SID Number: 30059180 Serial Number: STA2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3014-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3014-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-25

Product code OWB

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)