PHILIPS
Received Apr 30, 2026 · Event occurred Mar 22, 2026
Report 1056069-2026-000001 · MDR key 25040527
Device
Generic name
Coil, Magnetic Resonance, Specialty
Manufacturer
Philips Medical Systems Nederland B.v.Model number
SENTINELLE SMS 16CH BREAST 1.5TCatalog number
989603213622
Product problems
- Improper or Incorrect Procedure or Method
- Insufficient Device Problem Information
Patient
62 YR · Female
- Burn(s)
- Insufficient Information
Narrative
Additional Manufacturer Narrative
PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THIS INCIDENT HAS ALSO ALREADY BEEN REPORTED TO YOU VIA THE DISTRIBUTOR SIEMENS UNDER NUMBER 3002808157-2026-0000.
Description of Event or Problem
PHILIPS RECEIVED A REPORT ABOUT A POTENTIAL HEATING INCIDENT DURING A BREAST EXAMINATION WHILST USING THE 16 CHANNEL BREAST COIL. IT WAS REPORTED THE PATIENT COMPLAINED OF A BURN ON THE UNDERSIDE OF BOTH BREASTS. NO OTHER CLINICAL OR MEDICAL INFORMATION WAS PROVIDED.