INGENIA
Received Mar 25, 2026 · Event occurred Mar 11, 2026
Report 3042177665-2026-000015 · MDR key 24685659
Device
Generic name
Full-body Mri System, Superconducting Magnet
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INGENIA 3.0T CXCatalog number
781271
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL HAD BEEN DAMAGED AS THE MAGNET HOLE ADHESIVE STRIP HAD COME OFF. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Additional Manufacturer Narrative
THE QBC SEAL THAT WAS DAMAGED, WAS REPLACED AND THE SYSTEM WAS HANDED BACK TO THE CUSTOMER FOR USE. THE FAILURE OF THE QBC SEAL TO REMAIN IN PLACE IS CONSIDERED A MALFUNCTION. REMEDIAL ACTION: A FIELD ACTION WAS INITIATED UNDER 2023-PD-MR-013. A FIELD SAFETY NOTIFICATION WAS SENT TO THE CUSTOMERS INFORMING THEM ABOUT THIS POTENTIAL ISSUE. THE FIELD CORRECTION HAS SINCE BEEN MADE AVAILABLE TO THE FIELD IN DEC 2024.
Remedial action
- Modification/Adjustment