Data Foundry

Medical device recalls 2023

Giraffe OmniBed Carestation CS1 — Class II medical device recall Z-2100-2023

Ongoing recall by DATEX--OHMEDA, INC., reported 2023-07-12. GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been inst

Recall numberZ-2100-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDATEX--OHMEDA, INC., Wauwatosa, WI, United States
Recall initiated2023-05-19
Classified2023-07-06
Reported by FDA2023-07-12
Quantity4,540 units
Serial numbersHDGJ51159, HDGL50099, HDGL51734, HDGL51735, HDGL51737, HDGL51738, HDGM50736, HDGM50841, HDGM51179, HDGM51813, HDGM52119, HDGM52120, HDGN50464, HDGN50465, HDGN50466, HDGN50467, HDGN50468, HDGN50469, HDGN50470, HDGN50471, HDGN50472, HDGN50474, HDGN50475, HDGN50844, HDGN50845 and 148 more
Model numbers2074920-001-XXXXXX, 2082844-001-XXX, M1050205, M1135822, M1145475, M1145476, M1146098, M1149051, M1235957

Product

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 radiant

Reason for recall

GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

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-2100-2023. 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.