GIRAFFE OMNIBED
Received Aug 6, 2025 · Event occurred May 20, 2025
Report 3005860720-2025-00026 · MDR key 22726547
Device
Generic name
Incubator, Neonatal
Catalog number
NA
Lot number
NA
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. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Remedial action
- Recall