Data Foundry

Medical device recalls 2019

Giraffe OmniBed Carestation — Class I medical device recall Z-0539-2020

Terminated recall by GE Healthcare, LLC, reported 2019-12-11. Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside pan

Recall numberZ-0539-2020
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-10-11
Classified2019-12-03
Reported by FDA2019-12-11
Terminated2024-08-15
Quantity7,814 units
Model numbers2082844-001-XXXXXX, 2082844-001-XXXXXXXX

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0539-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.