MAUDE Adverse Event Report: CANON INC. Canon; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	MEXL-3020/S5
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had previously been scanned on the system with no issues, had open heart surgery and had a plate put in their chest, complained of a heat feeling on their chest during a post-surgery scan.Techs stopped scanning and brought patient to 1.5t titan on site and completed the scan without further incident.Post scan tech gave patient an ice pack and patient left and later called site to report redness in area of chest plate where heat/burn was felt and reported they will report the incident to the plate manufacturer.

• Brand Name: Canon
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): CANON INC.; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer (Section G): CANON INC.; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin, CA 92780 ; +1(714)483-1551
• MDR Report Key: 24675884
• Report Number: 2020563-2026-00003
• Device Sequence Number: 10360396
• Product Code: LNH
• UDI-Device Identifier: 04987670102615
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MEXL-3020/S5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 165 LB