Giraffe OmniBed Carestation CS1

• 2 recalls, same reason

  • Ongoing Z-2476-2026 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-0048-2025 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-2100-2023 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

• • Ongoing Z-0281-2020 FDA Class II ·initiated 26 Jul 2019

  Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

• • Completed Z-0140-2025 FDA Class I ·initiated 6 Jun 2023

  Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

• • Terminated Z-0539-2020 FDA Class I ·initiated 11 Oct 2019 ·on shared 510(k) K152814

  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-0479-2019 FDA Class II ·initiated 25 Sep 2018

  Potential electric leakage affecting the user.

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

510(k) Number

K152814 ↗

FDA Product Code

FMZ

FDA applicant

Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Giraffe Incubator Carestation CS1

  Class II

  FDA 510(k) K152809 Active Cleared 31 Dec 2015

• Giraffe and Panda Warmers

  Class II

  FDA 510(k) K122267 Active Cleared 2 Oct 2012

• Giraffe and Panda Warmers

  Class II

  CE/MDR FDA 510(k) K101804 Active Cleared 21 Jul 2010

• What is the Giraffe OmniBed Carestation CS1 used for?

  The Giraffe OmniBed Carestation CS1 is designed to provide a controlled, protected microenvironment for neonatal care, supporting infant thermal regulation and healing in general hospital settings.

• Is the Giraffe OmniBed Carestation CS1 reusable or single-use?

  The device is supplied as a reusable system, meaning it is intended for multiple uses after proper cleaning and reprocessing between patients.

• What regulatory clearance does the Giraffe OmniBed Carestation CS1 have?

  The Giraffe OmniBed Carestation CS1 has received FDA 510(k) clearance under submission number K152814 and is classified as a Class II medical device with product code FMZ.