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GE Healthcare - Giraffe and Panda T-Piece Resuscitation… recallZ-0748-2013 · GE Healthcare, LLC · initiated Oct 15, 2012

Class I Terminated All recalls posted in February 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-0748-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Oct 15, 2012
Posted by the FDA
Feb 8, 2013
Recalling firm
GE Healthcare, LLC
Quantity
276 units total, 109 of those nationwide.
Product code
BTL
FDA submissions
K070210
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 description

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.

Code information (models, lots, serial numbers)

Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599

Other devices under the same FDA submission

1 device cleared under K070210 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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