510(k) K152814 ยท FMZ Incubator, Neonatal
Giraffe OmniBed Carestation CS1
| Applicant | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company, Laurel MD, US |
| Decision | Substantially Equivalent, Mar 17, 2016 |
| Received | Sep 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX Open, Classified |
FMZ | None listed |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 Open, Classified |
FMZ | None listed |
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
1) 2082844-001-01040418;
2) 2082844-001-01046784;
3) 2082844-001-01052324;
4) 208284 Completed |
FMZ | None listed |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator Open, Classified |
FMZ | None listed |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Giraffe OmniBed Carestation CS1,
Model Numbers:
a. 2082844-001-XXX,
b. 2074920-001-XXXXXX,
c. M1050205,
d. M1135822,
e. M1145475,
f. M1145476,
g. M1235957,
h. M1149051,
i. M1146098;
Labe Open, Classified |
FMZ | None listed |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer Terminated |
FMT | None listed |
| Jul 26, 2019 | GE Healthcare, LLC Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both Open, Classified |
FMZ | None listed |
| Sep 25, 2018 | GE Healthcare, LLC Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.