GE SIGNA EXCITE 3.0T MR SYSTEM
Report
- Report Number
- 2183553-2025-00017
- Event Type
- Injury
- Date Received
- October 2, 2025
- Date of Event
- August 1, 2025
- Report Date
- November 14, 2025
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- PMA / PMN Number
- K041476
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 501
Narratives
B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED. AN ACOUSTIC PERFORMANCE TEST WAS PERFORMED PER NEMA STANDARDS PUBLICATION NO. MS4-2010 (ACOUSTIC NOISE MEASUREMENT PROCEDURE FOR DIAGNOSTIC MAGNETIC RESONANCE IMAGING DEVICES) AND IEC/CEI 60601-2-33 CLAUSE 26. THE TESTING CONCLUDED THAT THE SYSTEM WAS WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). THE PATIENT WAS PROVIDED PROPER HEARING PROTECTION DURING THE SCAN. HUMAN CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. NO SYSTEM ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.
LEGAL MANUFACTURER: HCS MR - 3200 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. D4: PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
A PATIENT WHO UNDERWENT AN MRI OF THE ORBITS REPORTED TO HAVE SUSTAINED BILATERAL HEARING LOSS AND NERVE DAMAGE AS DETERMINED BY AN AUDIOLOGIST ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2623357 | GE SIGNA EXCITE 3.0T MR SYSTEM | NUCLEAR MAGNETIC RESONANCE IMAGING | LNH | GE MEDICAL SYSTEMS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Other |