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Recall Observatory FDA recall evidence

Device product

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.

Z-0748-2013

October 15, 2012

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 63761
Status
Terminated
Classification
Class I
Quantity
276 units total, 109 of those nationwide.
Official record key
device-enforcement:Z-0748-2013

Official wording

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

Code information: Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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