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U.S. Department of Health and Human Services

Class 1 Device Recall Emergency Powered Ventilator Resusicitator

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 Class 1 Device Recall Emergency Powered Ventilator Resusicitator see related information
Date Posted February 25, 2014
Recall Status1 Open
Recall Number Z-1072-2014
Recall Event ID 67004
510(K)Number K070377  K090697  K101804  K122267 
Product Classification Warmer, infant radiant - Product Code BTL
Product 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.




Code Information 51765
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402081
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5296593
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HDJS
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact James Giles
262-548-2089
Manufacturer Reason
for Recall
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
FDA Determined
Cause 2
Component design/selection
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.
Quantity in Commerce 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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