ACHIEVA XR 1.5T/3.0T NEW
Received Apr 22, 2026 · Event occurred Apr 8, 2026
Report 3042177665-2026-000047 · MDR key 24949745
Device
Generic name
Full-body Mri System, Superconducting Magnet
Manufacturer
Philips Medical Systems Nederland B.v.Model number
ACHIEVA XR 1.5T/3.0T NEWCatalog number
781253
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 STRIP WAS LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Additional Manufacturer Narrative
THE ISSUE WITH THE QBC SEAL THAT HAD COME LOOSE, WILL BE RESOLVED ONCE THE FCO IS IMPLEMENTED. AT THIS MOMENT, THERE IS NO SCHEDULED ONSITE VISIT FOR THIS ACTIVITY. 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