Food, drugs, devices › GE Healthcare, LLC
Device recall: Giraffe OmniBed infant warmer
FDA enforcement event 84077 is a device recall by GE Healthcare, LLC of Waukesha, WI, initiated 11 Oct 2019 and classified Class I, with 4 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 15 Aug 2024. Initiation: voluntary: firm initiated. GE Healthcare, LLC has 225 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, LLC, Waukesha, WI.
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."
Distribution
"worldwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0538-2020 | Giraffe OmniBed infant warmer | 23,693 units | Class I | Terminated | 11 Dec 2019 |
| Z-0539-2020 | Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer | 7814 units | Class I | Terminated | 11 Dec 2019 |
| Z-0540-2020 | Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer | 3467 units | Class I | Terminated | 11 Dec 2019 |
| Z-0541-2020 | Giraffe Incubator infant warmer | 19425 units | Class I | Terminated | 11 Dec 2019 |
Context
Other enforcement events for GE Healthcare, LLC
All 225 events for GE Healthcare, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "worldwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.