FDA Medical Device Recalls (openFDA)
Ohmeda Medical, A Div of Datex-Ohmeda , Inc: Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
- Recall number
- Z-0288-04
- Recalling firm
- Ohmeda Medical, A Div of Datex-Ohmeda , Inc
- Product
- Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
- Status
- Terminated
- Initiated
- 2003-10-17
- Posted
- 2004-07-20
- Terminated
- 2005-10-11
- Reason
- Heater vent door on neonatal incubator may malfunction.
- 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
- 1404 beds
- Distribution
- Products were sold to 365 direct accounts around the US and 58 international distributors.
- Lot, serial or model codes
- HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where ''yyyyy'' represents any number less than 60000
- 510(k) numbers
- ["K020543"]
- 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