Events

Recall of Device Recall Emergency Powered Ventilator Resusicitator

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
    67004
  • Event Risk Class
    Class 1
  • Event Number
    Z-1072-2014
  • Event Initiated Date
    2013-10-01
  • Event Date Posted
    2014-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125259
  • 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
    Warmer, infant radiant - Product Code BTL
  • 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 November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.

Device

Device Recall Emergency Powered Ventilator Resusicitator
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.
  • Product Description
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer || Product Usage: || The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
  • 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