Events

Recall of Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ohmeda Medical, A division 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
    31665
  • Event Risk Class
    Class 2
  • Event Number
    Z-1047-05
  • Event Initiated Date
    2005-04-25
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38318
  • 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
    Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
  • 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.

Device

Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
  • Product Description
    Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Manufacturer
    Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Manufacturer

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