GE Healthcare, LLC: GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.

Recall number

Z-0606-2013

Recalling firm

GE Healthcare, LLC

Product

GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.

Status

Terminated

Initiated

2012-06-26

Posted

2012-12-26

Terminated

2014-04-14

Reason

Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

Root cause

Nonconforming Material/Component

Action

GE Healthcare sent an Urgent Medical Device Correction letter, dated June 26, 2012, with a return receipt to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction. Required Action for Users: Inspect existing stock of T-piece circuits to look for the Red inspection stamp, the T-pieces with the blue stamp are acceptable for clinical use. Separate affected circuits (with Red inspection stamp) from unaffected stock (with Blue inspection stamp). Destroy affected circuits that have the Red inspection stamp. Fill out the customer acknowledgement form and fax or forward to the GE contact address on the form. Further, it is recommended that healthcare professionals continue to emphasize the recommended pre-use checkout practices, and do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/- 5 cmH20. Clinicians should always use the built-in Airway Pressure Manometer to verify the PIP value. For questions or concerns regarding this notification, customers should call the following phone number: 1-800-345-2700.

Quantity

209,804 circuits

Distribution

Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates,

Lot, serial or model codes

7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.

510(k) numbers

K070210

PMA numbers

not on file

Product code

BTL

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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