Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resu

FDA device recall Z-0749-2013 · posted 2013-02-08 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

BTM

Quantity affected

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 co

Date initiated

2012-10-15

Date posted

2013-02-08

Date terminated

2017-01-18

Location

Waukesha, WI

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