Z-0288-04

Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed

Name: Z-0288-04 Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed
Creator: Ohmeda Medical, A Div of Datex-Ohmeda , Inc
Published: 2003-10-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2003-10-17 / Terminated

FDA source

Ohmeda Medical, A Div of Datex-Ohmeda , Inc began a recall of Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed on 2003-10-17. The reason FDA records is "Heater vent door on neonatal incubator may malfunction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0288-04
Status: Terminated
Initiated: 2003-10-17
Posted: 2004-07-20
Terminated: 2005-10-11
Recalling firm: GE Healthcare
Product: Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
Product code: FMZ Incubator, Neonatal
Reason for recall: Heater vent door on neonatal incubator may malfunction.
FDA root cause: Other
Action: The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.
Quantity in commerce: 1404 beds
Distribution: Products were sold to 365 direct accounts around the US and 58 international distributors.
Product codes and lots: HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where ''yyyyy'' represents any number less than 60000

Product code FMZ

K020543Class IIOhmeda Medical Giraffe OmnibedOhmeda Medical / cleared 2002-05-09

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)