inforMED
MalfunctionOWB

INNOVA

Received Jul 11, 2025 · Event occurred Jun 12, 2025

Report 9611343-2025-00008 · MDR key 22479607

Device

Generic name

Stationary Angiographic X-ray System

Model number

IGS 5 001

Product problems

  • Structural Problem
  • Structural Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

GE HEALTHCARE INVESTIGATION HAS DETERMINED THAT CUSTOMER DID NOT FOLLOW GE HEALTHCARE PRE-INSTALLATION REQUIREMENTS. THE GE HEALTHCARE CONTRACTOR REINFORCED THE CEILING-SUSPENDED SUPPORT TO ENSURE ITS STABILITY AND STRUCTURAL INTEGRITY. THE CONTRACTOR PROVIDED GE HEALTHCARE WITH CERTIFICATION AND A STRUCTURAL ANALYSIS OF THE SUBSTRUCTURE. A GE HEALTHCARE REPRESENTATIVE CONDUCTED AN INSPECTION AND CONFIRMED THAT THE SUPPORT WAS STABLE, WITH NO ABNORMAL NOISE OBSERVED FROM THE MONITOR DURING MOVEMENT. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE. THERE ARE NO PATIENT IDENTIFIERS AS THERE WAS NO PATIENT INVOLVED.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530.

Description of Event or Problem

CUSTOMER REPORTED A CREAKING NOISE FROM THE CEILING SUBSTRUCTURE WHICH SUPPORTS THE GE HEALTHCARE INNOVA 540 VASCULAR SYSTEM MONITOR SUSPENSION. THE NOISE WAS LIKELY DUE TO UNEVEN LOADING, CAUSING VIBRATION AND THE POTENTIAL RISK OF THE MONITOR SUSPENSION FALLING. THE MONITOR DID NOT FALL AND THERE WAS NO INJURY REPORTED. GE HEALTHCARE'S INVESTIGATION IS ON GOING.