ACHIEVA 1.5T

Additional Manufacturer Narrative

THE QBC RUBBER SEAL CAME APART FROM THE TUNNEL AND WAS DETACHED, 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) SEAL RUBBER WAS DETACHED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DETACHED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.