Z-0108-2027

Alphenix INFX-8000C/B5

Name: Z-0108-2027 Alphenix INFX-8000C/B5
Creator: Canon Medical System, USA, INC.
Published: 2026-08-26
License: https://open.fda.gov/license/

Canon Medical System, USA, INC. / initiated 2026-08-26 / Open, Classified

FDA source

Recall record

Recall number: Z-0108-2027
Status: Open, Classified
Initiated: 2026-08-26
Posted: 2026-10-07
Recalling firm: Canon Medical System, USA, INC.
Product: Alphenix INFX-8000C/B5
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA root cause: Process control
Action: On August 26, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction notification to affected consignees via mail. Canon ask consignees to take the following actions: 1. Should this problem occur before inspection of the tightening of the bolt(s) is implemented on your system, please stop using the device and call your service representative. 2. 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. 3. A representative of Canon Medical Systems USA will contact you to schedule a time to inspect the tightening and properly fixing of the bolt(s) to correct this issue with your system(s). 4. If you have any questions regarding this matter, please contact your service representative contact our InTouch team at (800) 521-1968 or by email at [email protected]. 5. Canon respectfully requests that the attached form be completed and returned via email to [email protected].
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of ID.
Product codes and lots: Serial no. B5F2532011/UDI: 4987670100192

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 2026-10-09. View this recall on fda.gov (opens on fda.gov)