FDA Medical Device Recalls (openFDA)
Ohmeda Medical, A division of Datex-Ohmeda, Inc.: Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
- Recall number
- Z-1047-05
- Recalling firm
- Ohmeda Medical, A division of Datex-Ohmeda, Inc.
- Product
- Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
- Status
- Terminated
- Initiated
- 2005-04-25
- Posted
- 2005-07-28
- Terminated
- 2007-01-11
- Reason
- Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K010222","K020543","K020547","K993407"]
- PMA numbers
- not on file
- Product code
- FMZ
- 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