INGENUITY TF PET/MR

Description of Event or Problem

PHILIPS RECEIVED A CUSTOMER COMPLAINT STATING A PHOTOPENIC ARTIFACT WAS DETECTED THROUGH THE LOWER LUNGS ON THE MAGNETIC RESONANCE ATTENUATION CORRECTED (MRAC) IMAGE. THE CUSTOMER ALSO NOTICED LOW UPTAKE IN THE INFERIOR WALL OF THE HEART THAT WAS ALSO DETECTED ON THE NON-ATTENUATION CORRECTIVE (NAC) IMAGES. THE ARTIFACT IS NOT PRESENT ON THE MR MAP OR NAC DATASET.

Additional Manufacturer Narrative

(B)(4). THERE IS A REMOTE POTENTIAL FOR FALSE-NEGATIVE INTERPRETATION IN PTS WITH NEOPLASM THAT COULD RESULT IN LACK OF TREATMENT LEADING TO THE NECESSITY FOR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. THERE WAS NO REPORT OF HARM TO A PT IN THIS CASE AND THE HARM IS NOT EXPECTED TO OCCUR DUE TO TRAINED INTERPRETING PHYSICIAN RECOGNIZING IMAGE ARTIFACT, AND DEFAULT DISPLAY OF NON-AC AND ATTENUATION MAP FOR COMPARISON. INSTRUCTIONS FOR USE INCLUDES REVIEW OF NON-ATTENUATION CORRECTION IMAGES (459800153451 REV. B P18). THIS REPORTED EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.