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U.S. Department of Health and Human Services

Class 1 Device Recall Giraffe and Panda Bag and Mask Resuscitation System

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 Class 1 Recall
Giraffe and Panda Bag and Mask Resuscitation System
see related information
Date Posted February 25, 2014
Recall Status1 Open
Recall Number Z-1071-2014
Recall Event ID 67004
Premarket Notification
510(K) Number
K070247 
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Code Information QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 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
DESIGN: 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.
510(K) Database 510(K)s with Product Code = BTM and Original Applicant = OHMEDA MEDICAL
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