ARTIS ZEE III FLOOR
Received Jun 26, 2026 · Event occurred Jun 9, 2026
Report 3004977335-2026-00115 · MDR key 25634499
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Siemens Healthineers AgModel number
10502501Product problems
- Radiation Output Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE, BUT IS SIMILAR TO THE ARTIS ZEE DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407. IN THE REPORTED CASE, THE CUSTOMER DID NOT CONTACT SIEMENS LOCAL SERVICE ORGANIZATION FOR SUPPORT. AS NO SERVICE VISIT WAS CONDUCTED AND NO ADDITIONAL REQUIRED INFORMATION (E.G., LOG FILES) IS AVAILABLE, A DETAILED AND VERIFIABLE ANALYSIS OF THE REPORTED MALFUNCTION CANNOT BE PERFORMED. THEREFORE, NO CONCLUSIVE ROOT CAUSE COULD BE DETERMINED.
Description of Event or Problem
SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III FLOOR SYSTEM. DURING AN EMERGENCY PROCEDURE, THE X-RAY FUNCTION WAS SUDDENLY BLOCKED. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATIVE SYSTEM. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.