Events

Recall of Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ohmeda Medical, A Div of Datex-Ohmeda , Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27490
  • Event Risk Class
    Class 2
  • Event Number
    Z-0288-04
  • Event Initiated Date
    2003-10-17
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29961
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Incubator, Neonatal - Product Code FMZ
  • Reason
    Heater vent door on neonatal incubator may malfunction.
  • 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.

Device

Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
  • Model / Serial
    HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where ''yyyyy'' represents any number less than 60000
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were sold to 365 direct accounts around the US and 58 international distributors.
  • Product Description
    Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
  • Manufacturer
    Ohmeda Medical, A Div of Datex-Ohmeda , Inc

Manufacturer

Ohmeda Medical, A Div of Datex-Ohmeda , Inc
  • Manufacturer Address
    Ohmeda Medical, A Div of Datex-Ohmeda , Inc, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA