MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	INFX-8000C/Z1
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During use of stent enhance on (b)(6) 2025 the system locked up.After system lock up, staff forced shutdown and was able to reboot only after multiple attempts.During this time, totaling more than 30 minutes staff were unable to perform fluoro or da and patient went into cardiac arrest.After system reboot the system operated normally and the procedure was completed successfully.
Event or Problem Description
During use of stent enhance on (b)(6) 2025 the system locked up.After system lock up staff forced shutdown and was able to reboot only after multiple attempts.During this time, totaling more than 30 minutes staff were unable to perform fluoro or da and patient went into cardiac arrest.After system reboot the system operated normally and the procedure was completed successfully.
Additional Manufacturer Narrative
Root cause analysis: system error occurred using stent enhancer function, after selecting f-store before closing function.System error related to software error.Corrective actions: manufacturer to provide revised software to prevent recurrence.Actions taken to prevent recurrence: identify and correct any code that accesses arrays using arguments.Check argument ranges in new code to prevent out-of-bounds access (added to code review perspective).

• Brand Name: CANON
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin, CA 92780 ; 7144831551
• MDR Report Key: 23832810
• Report Number: 2025632-2025-00010
• Device Sequence Number: 8954561
• Product Code: OWB
• UDI-Device Identifier: 04987670100192
• UDI-Public: 04987670100192
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INFX-8000C/Z1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown