ALLIA
Received Jun 26, 2026 · Event occurred Jun 2, 2026
Report 9611343-2026-00002 · MDR key 25632540
Device
Generic name
Interventional Fluoroscopic X-ray
Manufacturer
Ge Medical Systems ScsModel number
IGS 5Catalog number
5943307
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE, FRANCE BUC YVELINES, 78530. GE HEALTHCARE INVESTIGATION IS ONGOING; HOWEVER, ASSESSMENT IS LIMITED BY THE LACK OF ADDITIONAL PATIENT AND CLINICAL INFORMATION FROM THE CUSTOMER.
Description of Event or Problem
THE CUSTOMER REPORTED A POTENTIAL RADIATION OVEREXPOSURE AFTER OBSERVING A HIGHER ACCUMULATED DOSE ASSOCIATED WITH AN UNUSUALLY LONG FLUOROSCOPY EXPOSURE. THE GE HEALTHCARE VASCULAR SYSTEM WAS EVALUATED AND FOUND TO BE CORRECTLY CALIBRATED AND ACCURATELY REPORTING DOSE INFORMATION, AND NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. NO PATIENT IMPACT HAS BEEN REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING.