Data Foundry

Medical device recalls 2023

Giraffe OmniBed — Class II medical device recall Z-2101-2023

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-2101-2023
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
Quantity3,053 units
Model numbers6650-0001-901, 6650-0001-9901, 6650-0002-901, 6650-0003-901, 6650-0004-901, 6650-0006-901, 6650-001-901, 6650-0029-901, 6650-0032-901, 6650-0034-902, 6650-0042-902, 6650-0043-902, 6650-0056-902, 6650-0060-902, 6650-0061-902, 6650-0063-902, 6650-0066-902, 6650-0077-901, 6650-0080-901, 6650-0082-902, 6650-0094-901, 6650-0104-902, 6650-0107-902, 6650-0129-901, 6650-0130-901 and 5 more

Product

Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

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-2101-2023. 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.