GE Healthcare, LLC: Medical Device Recall in 2014 - (Recall #: Z-1071-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The 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.

Product Classification:

Class I

Date Initiated: October 1, 2013

Date Posted: March 5, 2014

Recall Number: Z-1071-2014

Event ID: 67004

Reason for Recall:

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

Status: Terminated

Product Quantity: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown

Code Information:

QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated