FDA-Device2013-02-20Class I
GE Healthcare - Giraffe and Panda T-Piece 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.
GE Healthcare, LLC
Hazard
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Sold states
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.
Affected count
276 units total, 109 of those nationwide.
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare - Giraffe and Panda T-Piece 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0748-2013Don't want to check this manually?
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