PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: February 20, 2013 Initiated: October 15, 2012 #Z-0749-2013

Product Description

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.

Reason for Recall

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE Healthcare, LLC. Units affected: 276 units total, 109 of those nationwide..
Why was this product recalled?
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 20, 2013. Severity: Critical. Recall number: Z-0749-2013.