INGENIA
Received Jun 16, 2026 · Event occurred May 18, 2026
Report 3042177665-2026-000093 · MDR key 25516393
Device
Generic name
Full-body Mri System, Superconducting Magnet
Manufacturer
Philips Medical Systems Nederland B.v.Model number
SMARTPATH TO DSTREAM FOR 3.0TCatalog number
781270
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) SEAL THAT IS BROKEN WILL BE REPLACED. AT THIS MOMENT, ONSITE ACTIVITY FOR THIS ISSUE IS STILL NOT SCHEDULED. THE FAILURE OF THE QBC SEAL TO REMAIN IN PLACE IS CONSIDERED A MALFUNCTION. REMEDIAL ACTION: A FIELD ACTION WAS INITIATED UNDER (B)(4). 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) UPPER SEAL WAS BROKEN. 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.
Remedial action
- Modification/Adjustment