Z-2392-2023Class II

Infx-8000C Xgcp-930Aa Table Side Console, Infx-8000C Xgcp-930Ba Table Side Console

Name: Z-2392-2023 Infx-8000C Xgcp-930Aa Table Side Console, Infx-8000C Xgcp-930Ba Table Side Console
Creator: Canon Medical System, USA, INC.
Published: 2023-06-22
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2023-06-22 / Open, Classified / root cause: manufacturing process

FDA source

Canon Medical System, USA, INC. began a recall of INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE on 2023-06-22. FDA classified it as Class II and gives the reason as "The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue...". 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-2392-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-22
Posted: 2023-08-11
Recalling firm: Canon Medical Systems USA, Inc.
Product: Infx-8000C Xgcp-930Aa Table Side Console, Infx-8000C Xgcp-930Ba Table Side Console
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to replace the PWB on the console. Complete and return the customer reply form to [email protected] For questions, contact the InTouch team at [email protected] or your service representative at 800.521.1968
Quantity in commerce: 12
Distribution: US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
Product codes and lots: UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2392-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2392-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-10

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)