MalfunctionJAA
ALLURA FC
Received May 25, 2026 · Event occurred Apr 28, 2026
Report 3042175844-2026-001053 · MDR key 25267613
Device
Generic name
System, X-ray, Fluoroscopic, Image-intensified
Manufacturer
Philips Medical Systems Nederland B.v.Model number
ALLURA FCCatalog number
723003
Product problems
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HOST COMPUTER WAS UNABLE TO BOOT, PREVENTING A FULL SYSTEM STARTUP. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.