Z-0748-2013Class I

GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator...

Name: Z-0748-2013 GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator...
Creator: GE Healthcare, LLC
Published: 2012-10-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-10-15 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask... on 2012-10-15. 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 manufacturing process.

Recall record

Recall number: Z-0748-2013
Classification: Class I
Status: Terminated
Initiated: 2012-10-15
Posted: 2013-02-08
Terminated: 2017-01-18
Recalling firm: GE Healthcare
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.
Product code: BTL Ventilator, Emergency, Powered (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: manufacturing process
FDA root cause: Employee error
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated October 15, 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: It is recommended that a qualified biomedical technician or respiratory therapist identify the affected resuscitation system and locate the air and oxygen fittings and labels at the back of the unit. With the table provided, identify the appropriate fitting for their country and location and verify the air fitting is located on the left side and the oxygen fitting is located on the right. Verify the air label is located on the left side and the oxygen label is on the right and verify that the color of the air and oxygen labels match the picture on table provided. If the unit does not meet all of the criteria, the unit will require repair. If the unit in use with patient, disconnect the wall supply gas and switch to tank supply. Once the patient no longer requires respiratory support, transfer the patient to another bed and remove the unit from service. A Field Engineer will be deployed to your site to complete the required repair. If the unit NOT in use with Patient, take the unit ouf of service. A Field Engineer will be deployed to your site to complete the required repair. For questions or concerns regarding this notification, please call the phone number 1-800-345-2700. For questions regarding this recall call 262-513-4122.
Quantity in commerce: 276 units total, 109 of those nationwide.
Distribution: 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.
Product codes and lots: Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-08
Z-0749-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-08

Product code BTL

K070210Class IIGiraffe and Panda T- Piece 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)