ACHIEVA 1.5T NEW

Additional Manufacturer Narrative

THE QBC SEAL THAT HAD COME LOOSE AND CAME OFF, WAS REPLACED AND THE SYSTEM WAS RETURNED 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 PART THAT THE FRONT CONE SEAL OF QBC WAS LOOSE AND IT WAS COMING 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.