ACHIEVA 1.5T DSTREAM
Received Jun 26, 2026 · Event occurred Jun 9, 2026
Report 3042177665-2026-000099 · MDR key 25633421
Device
Generic name
System, Nuclear Magnetic Resonance Imaging
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 QBC SEAL THAT WAS COME OFF, WAS REGLUED 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 RUBBER ON QBC 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 LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Remedial action
- Modification/Adjustment