ELITION 3T MRI

Description of Event or Problem

ORIGINAL EQUIPMENT MANUFACTURER (OEM) ISSUE WITH QUALITY ON BODY COILS FOR INGENIA 3T MRI. UNIT INSTALLED (B)(6) 2021. FIRST BODY COIL FAILED ON (B)(6) 2025. REPLACEMENT BODY COIL ARRIVED (B)(6) 2025 AND WAS DETERMINED TO BE OUT OF BOX FAILURE. 2ND REPLACEMENT BODY COIL ARRIVED (B)(6) 2025 WHICH WAS INSTALLED ALONG WITH AN RF AMP. SYSTEM WORKED FOR 4 DAYS AND WAS DOWN AGAIN (B)(6) 2025. A 3RD BODY COIL AND 2ND RF AMP WAS ORDERED AND REPLACED, AND THE SYSTEM WAS FINALLY PUT BACK IN SERVICE BY THE VENDOR ON (B)(6) 2025. NOW LESS THAN 8 MONTHS LATER, ON (B)(6) 2026 THE BODY COIL FAILED AGAIN. 2025 ISSUE WAS PHILIPS CASE NUMBER (B)(4). SITE HAS CONCERNS OVER THE QUALITY MANAGEMENT SYSTEM REVIEWING AND VALIDATING PARTS FOR MRI SYSTEMS. TYPICAL LIFE OF BODY COILS IS 7 YEARS. THIS UNIT HAS SEEN 4 BODY COILS IN 5 YEARS. ADDITIONALLY, THE MULTIPLE OUT OF BOX FAILURES OF PARTS WAS REQUESTED TO BE ESCALATED AND RESEARCHED WITHIN PHILIPS QUALITY SYSTEM AND NO FEEDBACK ON THAT ANALYSIS HAS BEEN PROVIDED TO THE CUSTOMER. THIS MODEL HAS ALSO BEEN THE SUBJECT OF 8 RECALLS IN ITS 5 YEAR LIFE. PLEASE REVIEW QMS OF THIS VENDOR AND INVESTIGATE HANDLING OF COMPLAINTS AND CONCERNS. PT CODE: 4582. DEVICE CODES: 3270, 4019, 1506. REF: MW5186993, MW5186994, MW5186995.