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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

DATEX--OHMEDA, INC.: Giraffe OmniBed Incubators Recalled Due to Loose Warmer Heater Door Screws

Agency Publication Date: October 17, 2024
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Summary

GE HealthCare has recalled certain Giraffe OmniBed and Giraffe OmniBed Carestation neonatal incubators because a screw securing the warmer heater doors may not have been tightened properly during manufacturing. This defect can cause the doors to become loose or detached. These specialized incubators are used in hospitals to provide controlled environments for newborn infants. Healthcare facilities with these devices should check for affected models, including the OmniBed Carestation (Model 2082844-001-XXX) and all original Giraffe OmniBed models.

Risk

If the screws securing the warmer heater doors become loose, the doors may fail to stay in place, potentially exposing the heating element or interfering with the incubator's temperature regulation. This poses a risk of thermal injury or an unstable environment for vulnerable neonatal patients.

What You Should Do

  1. Identify if your facility is using the GE Healthcare Giraffe OmniBed (all models) or the Giraffe OmniBed Carestation (Model Number 2082844-001-XXX).
  2. Inspect the doors covering the warmer heaters on affected units to ensure they are secure and that the fastening screws show no signs of loosening.
  3. Contact GE HealthCare at 1-800-437-1171 or visit their website to coordinate a technical inspection and torque verification of the heater door screws by a qualified service representative.
  4. Immediately report any loose parts or equipment malfunctions to your facility's biomedical engineering department and the manufacturer.
  5. For additional questions or to report safety concerns, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Inspection and technical adjustment

How to: Contact your healthcare provider or the manufacturer for further instructions regarding technical service to ensure screws are torqued to specification.

Affected Products

Product: GE Heathcare Giraffe OmniBed neonatal incubator
Model / REF:
All models
Lot Numbers:
Recall #: Z-0047-2025
Product: GE Heathcare Giraffe OmniBed Carestation neonatal incubator
Model / REF:
2082844-001-XXX
All models
Lot Numbers:
Recall #: Z-0048-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95282
Status: Active
Manufacturer: DATEX--OHMEDA, INC.
Sold By: GE HealthCare authorized distributors
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.