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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

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

Agency Publication Date: December 3, 2019
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Affected Products

Product: Giraffe OmniBed infant warmer

Model Numbers: 6650-0XXX-XXX 2074920-00X-XXXXXX M1050205 M1136116 M1136215 M1139253 M1145528 M1145529 M1146094 M1149051 M1149079 M1149081 M1149087 M1149108 M1161324 M1161328 M1161338 M1162796 M1206147 M1235957 Updated 6/3/2021 - All model numbers and units are affected.

Product: Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer

Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX Updated 6/3/2021 - All model numbers and units are affected.

Product: Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer

Giraffe Incubator Carestation, Model Numbers:2082844-002-XXXXXX Updated 6/3/2021 - All model numbers and units are affected.

Product: Giraffe Incubator infant warmer

Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84077
Status: Resolved
Manufacturer: GE Healthcare, LLC
Manufactured In: United States
Units Affected: 4 products (23,693 units; 7814 units; 3467 units; 19425 units)
Agency Last Updated: June 4, 2021

Were You Affected by This Recall?

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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 · 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.