FDA Medical Device Recalls (openFDA)
Ohmeda Medical, A division of Datex-Ohmeda, Inc.: Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
- Recall number
- Z-1064-03
- Recalling firm
- Ohmeda Medical, A division of Datex-Ohmeda, Inc.
- Product
- Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
- Status
- Terminated
- Initiated
- 2003-06-13
- Posted
- 2003-07-29
- Terminated
- 2003-07-29
- Reason
- Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
- 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
- 157 units
- Distribution
- Devices were sold to 15 international distributors and one domestic end user.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K020543","K020547"]
- PMA numbers
- not on file
- Product code
- 80FMZ
- Firm FEI
- 1121732
- Firm city
- Laurel
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28