ACHIEVA 1.5T DSTREAM
Received Jun 29, 2026 · Event occurred Jun 10, 2026
Report 3042177665-2026-000100 · MDR key 25648639
Device
Generic name
Full-body Mri System, Superconducting Magnet
Manufacturer
Philips Medical Systems Nederland B.v.Model number
SMARTPATH TO DSTREAM FOR 1.5TCatalog number
782112
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE QUADRATURE BODY COIL (QBC) BODY RUBBER SEAL HAD COME LOOSE, 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.
Description of Event or Problem
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) RUBBER SEAL HAD COME 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.
Remedial action
- Modification/Adjustment