GIRAFFE OMNIBED
Received Sep 30, 2025 · Event occurred Sep 3, 2025
Report 3036470679-2025-00007 · MDR key 23179681
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (RECALL NO. Z-0047-2025 & Z-0048-2025), THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-0047-2025 & Z-0048-2025. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS HEATER DOOR ISSUE PER 21 CFR 806 ON 22-OCT-2024. THE FDA RECALL NUMBER IS Z-0047-2025 & Z-0048-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING, INSTALLING, AND TIGHTENING THE SCREW THAT SECURES THE HEATER DOOR. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK H4: DATE OF DEVICE MANUFACTURE YEAR IS 2006. THE MONTH OF MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Remedial action
- Recall