TEC
Received May 5, 2026 · Event occurred Apr 7, 2026
Report 2112667-2026-03009 · MDR key 25084134
Device
Product problems
- Insufficient Flow or Under Infusion
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE WAS RELATED TO RECALL NO. Z-0814-2025. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT PER 21 CFR 806 ON 27-NOV-2024. THE FDA RECALL NUMBER IS (RECALL NO. Z-0814-2025). CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING FOR CORRECT OUTPUT CONCENTRATION. GEHC WILL REPLACE ALL AFFECTED UNITS.
Additional Manufacturer Narrative
GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN LOW AGENT OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.
Remedial action
- Recall