Giraffe Omnibed Carestation CS1— 510(k) K213551

Clearance details

Applicant

Datex Ohmeda, Inc.

Product code

Code FMT

Device class

Class 2

Regulation

21 CFR 880.5130

Advisory panel

General Hospital

Date received

2021-11-08

Decision date

2022-03-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wauwatosa, WI, US

• K243606 — Babyroo TN3002025-01-17
• K230278 — Babyroo TN3002023-05-30
• K201628 — Panda iRes Warmer, Giraffe Warmer2021-02-12
• K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2020-04-02
• K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover2020-01-21

• K254036 — Novii+ Wireless Patch System2026-08-10
• K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2026-07-28
• K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
• K213867 — Carestation 750/750c2023-03-28
• K213553 — Giraffe Incubator Carestation CS12022-03-02

Death

4

Malfunction

3,074

Total

3,078

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2476-2026 — Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXXClass II·Ongoing·GE Medical Systems, LLC·20260501
• Z-2477-2026 — Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500Class II·Ongoing·GE Medical Systems, LLC·20260501
• Z-0048-2025 — GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubatorClass I·Ongoing·DATEX--OHMEDA, INC.·20240903
• Z-0140-2025 — 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) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmerClass I·Completed·DATEX--OHMEDA, INC.·20230606
• Z-2100-2023 — 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; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiantClass II·Ongoing·DATEX--OHMEDA, INC.·20230519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213551.