Events

Recall of Giraffe and Panda Bag and Mask Resuscitation System

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

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
    63761
  • Event Risk Class
    Class 1
  • Event Number
    Z-0749-2013
  • Event Initiated Date
    2012-10-15
  • Event Date Posted
    2013-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115555
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Reason
    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated October 15, 2012, with a return receipt to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction. Required Action for Users: It is recommended that a qualified biomedical technician or respiratory therapist identify the affected resuscitation system and locate the air and oxygen fittings and labels at the back of the unit. With the table provided, identify the appropriate fitting for their country and location and verify the air fitting is located on the left side and the oxygen fitting is located on the right. Verify the air label is located on the left side and the oxygen label is on the right and verify that the color of the air and oxygen labels match the picture on table provided. If the unit does not meet all of the criteria, the unit will require repair. If the unit in use with patient, disconnect the wall supply gas and switch to tank supply. Once the patient no longer requires respiratory support, transfer the patient to another bed and remove the unit from service. A Field Engineer will be deployed to your site to complete the required repair. If the unit NOT in use with Patient, take the unit ouf of service. A Field Engineer will be deployed to your site to complete the required repair. For questions or concerns regarding this notification, please call the phone number 1-800-345-2700. For questions regarding this recall call 262-513-4122.

Device

Giraffe and Panda Bag and Mask Resuscitation System
  • Model / Serial
    Model M1139612
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.
  • Product Description
    Giraffe and Panda Bag and Mask Resuscitation System || The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA