Z-1071-2014Class I

GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation...

Name: Z-1071-2014 GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation...
Creator: GE Healthcare, LLC
Published: 2013-10-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-10-01 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask... on 2013-10-01. FDA classified it as Class I and gives the reason as "Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1071-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-01
Posted: 2014-02-25
Terminated: 2016-07-22
Recalling firm: GE Healthcare
Product: 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 code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Root cause tag: design
FDA root cause: Component design/selection
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.
Quantity in commerce: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
Distribution: 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.
Product codes and lots: QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25
Z-1071-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25
Z-1072-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code BTM

K070247Class IIGiraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical / cleared 2007-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)