CLASS I Device recall · Reported 20 Feb 2013 · FDA Enforcement Report

Giraffe and Panda Bag and Mask Resuscitation System recalled

GE Healthcare is recalling Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System, distributed in 31 states. The recall was initiated on 15 Oct 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel M1139612

Quantity recalled276 units total, 109 of those nationwide.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0749-2013
FDA event ID: 63761
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class I
Status: Terminated
Recall initiated: 15 Oct 2012
FDA classified: 8 Feb 2013
Reported: 20 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

15 Oct 2012	Recall initiated by company
8 Feb 2013	Classified by FDA	+116 days
20 Feb 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arizona California Colorado Florida Georgia Iowa Idaho Illinois Kentucky Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model M1139612

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 63761

Reported	Class	Recall	Company	Reason	Where
20 Feb 2013	CLASS I	Giraffe and Panda T-Piece Resuscitation System The T-piece recalled	GE Healthcare	Other	31 states

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