GIRAFFE IRS
Received Jul 8, 2026 · Event occurred Jun 11, 2026
Report 3036470679-2026-00104 · MDR key 25749867
Device
Generic name
Ventilator, Emergency, Powered
Manufacturer
Datex-ohmeda, Inc.Model number
T-PIECECatalog number
NA
Lot number
NA
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT CAN DELIVER AN OXYGEN CONCENTRATION THAT DOES NOT MATCH THE INTENDED CONCENTRATION SET BY THE USER AND MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 20-MAY-2026 (RECALL NO. Z-2357-2026, Z-2358-2026, Z-2359-2026). THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR AN ISSUE THAT CAN DELIVER AN OXYGEN CONCENTRATION THAT DOES NOT MATCH THE INTENDED CONCENTRATION SET BY THE USER PER 21 CFR 806 ON 20-MAY-2026. THE FDA RECALL NUMBER IS Z-2357-2026, Z-2358-2026, Z-2359-2026. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND PROVIDING INSTRUCTIONS FOR INSPECTING FOR DEVICES THAT HAVE AN AFFECTED BLENDER. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO PATIENT INFORMATION AVAILABLE. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Remedial action
- Recall