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U.S. Department of Health and Human Services

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 Class 1 Recall
Giraffe and Panda Warmer TPiece Resuscitation System
see related information
Date Posted February 25, 2014
Recall Status1 Open
Recall Number Z-1070-2014
Recall Event ID 67004
Premarket Notification
510(K) Number
K070210 
Product Classification Ventilator, Emergency, Powered (Resuscitator) - Product Code BTL
Product GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: 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. 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 QABR50042, QABR50036, QABR50082, QABR50110, QABR50111, QABR50031, QABR50008, QABS50107, QABS50108, QABS50139, QABR50009, QABR50043, QABS50017, QABS50072, QABS50129, QABS50076, QABR50005, QABR50060, QABR50035, QABS50084, QABS50100, QABR50038, QABR50023, QABR50095, QABR50097, QABS50151, QABS50153, QABS50154, QABR50137, QABR50144, QABR50002, QABR50001, QABR50015, QABS50119, QABS50122, QABR50112, QABR50129, QABS50098, QABS50099, QABS50101, QABR50124, QABR50141, QABR50028, QABS50148, QABR50109, QABR50030, QABR50217, QABR50159, QABR50160, QABR50161, QABR50163, QABR50165, QABR50166, QABR50167, QABR50172, QABR50173, QABR50174, QABR50175, QABR50176, QABR50177, QABR50178, QABR50179, QABR50180, QABR50181, QABR50182, QABR50183, QABR50184, QABR50185, QABR50186, QABR50187, QABR50188, QABR50189, QABR50190, QABR50191, QABR50192, QABR50193, QABR50195, QABR50209, QABR50211,QABR50212, QABR50213, QABR50214, QABR50216, QABR50219, QABR50220, QABR50222, QABR50223, QABR50224, QABR50225,QABR50232, QABR50233, QABR50234, QABR50235, QABR50236, QABR50237, QABS50120, QABS50130, QABS50132, QABR50218, QABR50221, QABR50019, QABR50032, QABR50139, QABR50142, QABR50164, QABR50194, QABR50198, QABR50199, QABR50130, QABR50046, QABR50025, QABR50058, QABR50059, QABR50033, QABR50039, QABR50061, QABR50062, QABR50063, QABR50006, QABR50048, QABS50052, QABS50053, QABS50067, QABS50028, QABS50050, QABS50051, QABR50047, QABS50083, QABR50020, QABS50025, QABS50029, QABR50016, QABR50169, QABR50170, QABR50171, QABS50071, QABS50118, QABS50147, QABR50040, QABR50044, QABR50078, QABR50084, QABR50150, QABR50231, QABR50014, QABS50077, QABS50078, QABS50079, QABS50134, QABS50140, QABS50131, QABR50208, QABR50210, QABS50018, QABS50019, QABS50150, QABS50149, QABS50160, QABR50041, QABR50022, QABR50017, QABR50010, QABR50012, QABR50136, QABR50138, QABS50024, QABS50048, QABS50049, QABR50135, QABR50143, QABR50145, QABR50146, QABR50147, QABR50162, QABR50196, QABR50197, QABR50200, QABR50201, QABR50003, QABR50051, QABR50052, QABR50057, QABR50096, QABR50098, QABR50099, QABR50081, QABS50020, QABS50016, QABR50134, QABR50080, QABR50083, QABS50117, QABS50141, QABR50148, QABR50151, QABR50152, QABS50061, QABS50062, QABS50105, QABS50136, QABS50075, QABR50115, QABS50152, QABR50054, QABR50029, QABS50142, QABS50143, QABS50095, QABS50097, QABR50055, QABR50094, QABS50064, QABS50065, QABS50066, QABS50080, QABS50081, QABS50082, QABR50114, QABR50027, QABR50056, QABR50131, QABR50037, QABR50007, QABS50133, QABR50215, QABS50121,QABR50140, QABR50034, QABR50024, QABR50079, QABR50049, QABR50050, QABS50073, QABS50074, QABR50011, QABR50125, QABR50018, QABR50026, QABR50004, QABR50113, QABR50168, QABR50053, QABR50077, QABR50085, QABS50015, QABR50045, QABR50013, QABR50021, QABR50149, QABR50153, QABS50031, QABS50032, QABS50058, QABS50059, QABS50060, QABS50063, QABR50203, QABR50204, QABR50093, QABS50106, QABS50123, QABS50124, QABS50125, QABS50126, QABS50137 QABS50138, QABR50205, QABR50207, QABS50104, QABS50022, QABS50055, QABS50056, QABS50057, QABS50128, QABS50096, QABR50202, QABS50014 QABS50111 QABS50112 QABS50113 QABS50114 QABS50033 QABS50034 QABS50035 QABS50036 QABS50037 QABS50038 QABS50039 QABS50040 QABS50041 QABS50042 QABS50043 QABS50044 QABS50045 QABR50238 QABR50239 QABR50240 QABR50241 QABR50242 QABR50243 QABR50244 QABR50245 QABR50246 QABR50247 QABR50248 QABR50249 QABR50250 QABR50251 QABR50252 QABR50254 QABR50255 QABR50256 QABR50257 QABR50258 QABR50259 QABR50260 QABR50261 QABR50262 QABR50263 QABR50264 QABR50265 QABR50266 QABR50267 QABR50269 QABR50270 QABR50271 QABR50272 QABR50273 QABS50046 QABS50135 QABS50007 QABS50009 QABS50030 QABS50047 QABR50120 QABR50121 QABS50085 QABS50144 QABS50145 QABR50127 QABS50087 QABS50088 QABS50089 QABR50128 QABR50154 QABR50155 QABR50156 QABR50157 QABR50158 QABR50268 QABS50109 QABS50110 QABR50226 QABR50228 QABR50227 QABR50229 QABR50253 QABS50001 QABS50002 QABS50003 QABS50004 QABS50005 QABS50006 QABS50008 QABS50010 QABS50011 QABS50012 QABS50013 QABS50068 QABS50090 QABS50091 QABS50092 QABS50093 QABS50094 QABS50127
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 = BTL and Original Applicant = OHMEDA MEDICAL
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