Giraffe OmniBed Neonatal Incubator

• 2 recalls, same reason

  • Ongoing Z-2475-2026 FDA Class II ·initiated 1 May 2026
  • Ongoing Z-2477-2026 FDA Class II ·initiated 1 May 2026

  GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

• • Ongoing Z-0047-2025 FDA Class I ·initiated 3 Sep 2024

  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.

• • Ongoing Z-2101-2023 FDA Class II ·initiated 19 May 2023

  GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

• • Terminated Z-2235-2020 FDA Class II ·initiated 28 Apr 2020

  Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

• • Terminated Z-2111-2020 FDA Class II ·initiated 2 Apr 2020

  During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

• • Terminated Z-0538-2020 FDA Class I ·initiated 11 Oct 2019 ·on shared 510(k) K101788

  Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

• • Terminated Z-1051-2013 FDA Class I ·initiated 8 Jan 2013

  Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Giraffe Omnibed

510(k) Number

K101788 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

• Ohmeda Medical Omnibed

  Class II

  FDA 510(k) K993407 Active Cleared 5 Jan 2000

• Ohmeda 7900 Anesthesia Ventilator

  Class II

  FDA 510(k) K960964 Active Cleared 27 Sep 1996

• Biliblanket Plus High Output Phototherapy System

  Class II

  FDA 510(k) K993712 Active Cleared 9 Nov 1999

• Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K871398 Active Cleared 7 May 1987

• Ohmeda 9000 Syringe Pump

  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

See all devices from Ohmeda Medical →

• What is the Giraffe OmniBed neonatal incubator designed for?

  The Giraffe OmniBed is specifically designed to provide a controlled microenvironment for newborns, particularly in neonatal intensive care units (NICUs) and general hospital wards. It maintains optimal temperature, humidity, and oxygen levels to support infant care and promote healing in vulnerable patients.

• Is the Giraffe OmniBed a single-use or reusable device?

  The Giraffe OmniBed is a reusable medical device intended for use in sterile or near-sterile conditions within neonatal care settings. It is not designed with disposable or single-use components, ensuring long-term functionality when properly maintained.

• What storage conditions are required for the Giraffe OmniBed?

  The device must be stored in a clean, dry environment to preserve its functionality. Proper storage is essential to maintain its performance and ensure compliance with regulatory standards for neonatal care equipment.

• Does the Giraffe OmniBed have interchangeable components?

  Yes, the Giraffe OmniBed features a modular design with interchangeable components. This allows for customization to meet varying clinical needs, including maternal-infant care environments, and ensures compatibility with existing hospital infrastructure.

• Is the Giraffe OmniBed MRI-safe?

  No, the Giraffe OmniBed is not MRI-safe. Clinicians should ensure the device is not placed in or near an MRI scanner to avoid potential interference or safety risks.