Z-1047-05

Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators

Name: Z-1047-05 Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
Creator: Ohmeda Medical, A division of Datex-Ohmeda, Inc.
Published: 2005-04-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-04-25 / Terminated

FDA source

Ohmeda Medical, A division of Datex-Ohmeda, Inc. began a recall of Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators on 2005-04-25. The reason FDA records is "Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1047-05
Status: Terminated
Initiated: 2005-04-25
Posted: 2005-07-28
Terminated: 2007-01-11
Recalling firm: GE Healthcare
Product: Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
Product code: FMZ Incubator, Neonatal
Reason for recall: Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
FDA root cause: Other
Action: Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.
Quantity in commerce: 1674 devices
Distribution: The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
Product codes and lots: Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367

Product code FMZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)