TEC
Received Jul 9, 2026 · Event occurred Jul 1, 2026
Report 2112667-2026-04389 · MDR key 25771322
Device
Product problems
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
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. BLOCK A: NO PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Remedial action
- Recall