ALLURA XPER FD
Received Dec 13, 2022 · Event occurred Nov 8, 2022
Report 3003768277-2022-01521 · MDR key 15974138
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
ALLURA XPER FD20Catalog number
722012
Product problems
- No Display/Image
- No Display/Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT THEY WERE UNABLE TO EXPOSE AND IMAGING WAS UNAVAILABLE. THE ISSUE WAS FOUND DURING CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS.
Additional Manufacturer Narrative
PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT ABLE TO EXPOSE. UPON INSPECTION, FSE DETERMINED THAT THE DETECTOR WAS FAULTY. THE FSE REPLACED THE IMAGING DETECTOR AND RAN ALL CALIBRATIONS. AFTER REPLACEMENT OF IMAGING DETECTOR, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.