PRODIGY

Additional Manufacturer Narrative

GE HEALTHCARE (GEHC) COMPLETED AN INVESTIGATION INTO THE REPORTED EVENT AND DETERMINED THE INJURY WAS ASSOCIATED WITH USER HANDLING OF THE ENCAPSULATED PHANTOM. THE USER WAS TRANSPORTING THE PHANTOM FROM A STORAGE AREA TO THE SYSTEM TABLE USING A CARRYING BAG WITH HANDLES. AS THE USER APPROACHED THE TABLE, THE HANDLES WERE INADVERTENTLY RELEASED, RESULTING IN THE PHANTOM DROPPING AND IMPACTING THE USERS RIGHT TOE. A GEHC FIELD ENGINEER SUBSEQUENTLY EVALUATED THE PHANTOM AND CONFIRMED THAT IT REMAINED WITHIN EXPECTED PERFORMANCE SPECIFICATIONS; THEREFORE, NO REPLACEMENT WAS REQUIRED. REVIEW OF THE EVENT DID NOT IDENTIFY A NEED FOR USER RETRAINING, AS THE HANDLING PRECAUTIONS ARE INHERENT TO THE ACTIVITY AND NO DEVICE MALFUNCTION WAS OBSERVED. BASED ON THE INVESTIGATION, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME.

Additional Manufacturer Narrative

GE HEALTHCAREÂ'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

Description of Event or Problem

ON (B)(6) 2025, (B)(6) REPORTED AN INCIDENT INVOLVING A PRODIGY DENSITOMETRY SYSTEM PHANTOM. DURING HANDLING, THE PHANTOM WAS ACCIDENTALLY DROPPED, STRIKING THE OPERATORÂ'S FOOT, CAUSING A FRACTURE IN THE RIGHT FOOT BIG TOE. NO DEVICE MALFUNCTION WAS REPORTED; THE EVENT OCCURRED DURING ROUTINE HANDLING OF THE PHANTOM. ALTHOUGH THE INJURY OCCURRED ON (B)(6) 2025, THE CUSTOMER DID NOT INFORM GE HEALTHCARE UNTIL 10-DEC-2025.