Z-1064-03

Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators

Name: Z-1064-03 Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Creator: Ohmeda Medical, A division of Datex-Ohmeda, Inc.
Published: 2003-06-13
License: https://open.fda.gov/license/

GE Healthcare / initiated 2003-06-13 / Terminated / root cause: manufacturing process

FDA source

Ohmeda Medical, A division of Datex-Ohmeda, Inc. began a recall of Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators on 2003-06-13. The reason FDA records is "Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1064-03
Status: Terminated
Initiated: 2003-06-13
Posted: 2003-07-29
Terminated: 2003-07-29
Recalling firm: GE Healthcare
Product: Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Product code: 80FMZ
Reason for recall: Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator.
Quantity in commerce: 157 units
Distribution: Devices were sold to 15 international distributors and one domestic end user.
Product codes and lots: Giraffe OmniBeds (w/Servo O2 option): HEDF50041 - HEDF50076 HDGE50562 ¿ HDGE50567, HDGF54039, HDGF54153 ¿ HDGF54155 HDGF54165 ¿ HDGF54167 Giraffe Incubators (w/Servo O2 option): HDHE50160-HDHE50161, HDHF50023-HDHF50024, HDHF50105, HDHF50109, HDHF50114, HDHF50227- HDHF50245, HDHF50278, HDHF50302, HDHF50304, HDHF50306, HDHF50309, HDHF50327-HDHF50328, HDHF50333-HDHF50343, HDHF53070, HDHF54046, HDHF54122, HDHF54131-HDHF54133, HDHF54135, HDHF54143-HDHF54145, HDHF54152-HDHF54155.

Product code 80FMZ

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)