Devices

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

Model / Serial
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 Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Devices were sold to 15 international distributors and one domestic end user.
Product Description
Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Manufacturer
Ohmeda Medical, A division of Datex-Ohmeda, Inc.
1 Event
- Recall of Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators

Manufacturer

Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Manufacturer Address
Ohmeda Medical, A division of Datex-Ohmeda, Inc., 8880 Gorman Road, Laurel MD 20723
Source
USFDA

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