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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 08, 2013
Recall Status1 Open
Recall Number Z-0749-2013
Recall Event ID 63761
Premarket Notification
510(K) Number
K070247 
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product 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.
Code Information Model M1139612
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact Gwen Braeger
262-513-4122
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
TRAINING: Employee Error
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.
Quantity in Commerce 276 units total, 109 of those nationwide.
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.
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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