Events

Recall of Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex Ohmeda, Inc. dba GE Healthcare.

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
    32920
  • Event Risk Class
    Class 2
  • Event Number
    Z-0160-06
  • Event Initiated Date
    2005-08-05
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41078
  • 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
    Unit, Neonatal Phototherapy - Product Code LBI
  • Reason
    Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
  • Action
    The firm notified consignees by letter on 08/05/2005 and advised of field correction of the devices in 2 phases. The letter is lot specific and provides for an interim workaround and includes an adhesive sticker and instructions for tagging the device with a warning statement containing restriction for use : 'This phototherapy light should ONLY be used on patients in closed incubators.' The letter further advises of firm''s plan to provide free, mandatory repair at a later date, pending hardware solution.

Device

Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System
  • Model / Serial
    Serial numbers: HEBE50008 - HEBE50019;  HEBF50001 - HEBF50311;  HEBG50001 - HEBG50751;  HEBH50001 - HEBH50950;  HEBJ50000 - HEBJ50432;  HEBG54001 - HEBG54035;  HEBH54001 - HEBH54999; HEBH55000 - HEBH55041;  HEBJ55033 - HEBJ55036;
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to medical facilities in the US and international subsidiaries and distributors.
  • Product Description
    Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • Manufacturer Address
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA