Home / Recalls / DATEX--OHMEDA, INC. / Z-0047-2025

Z-0047-2025 Class I Ongoing

Recalled by DATEX--OHMEDA, INC. — Wauwatosa, WI

Recall Details

Product Type
Devices
Report Date
October 23, 2024
Initiation Date
September 3, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

GE Heathcare Giraffe OmniBed; neo natal incubator

Reason for Recall

GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

Distribution Pattern

Worldwide distribution.

Code Information

All models

Other recalls by DATEX--OHMEDA, INC.

  • Z-0048-2025 Class I — GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo nata (September 3, 2024)
  • Z-0140-2025 Class I — GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and (June 6, 2023)
  • Z-0141-2025 Class I — GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers (June 6, 2023)
  • Z-2100-2023 Class II — Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 20749 (May 19, 2023)
  • Z-2101-2023 Class II — Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, (May 19, 2023)
  • Z-2102-2023 Class II — Beside panel FRU (Field Replacement Units) Kits (May 19, 2023)