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Voluntary Worldwide Field Corrective Action Issued for the T-piece Circuit used on GE Healthcare’s Giraffe and Panda



  Voluntary Worldwide Field Corrective Action Issued for the T-piece Circuit
  used on GE Healthcare’s Giraffe and Panda Resuscitation Units

Business Wire

LAUREL, Md. -- December 26, 2012

On June 26, 2012, GE Healthcare initiated a voluntary worldwide field
correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda
resuscitation units. The T-piece circuits affected by this recall are sold
under the following part numbers and contain a red inspection stamp (those
containing a blue inspections stamp are NOT affected by this recall):

  * M1091335 Kit, Circuit, T-Piece Disposable, 10 pack
  * M1091316 Kit, Circuit, T-Piece Disposable, W MASK Size 0, 10 pack
  * M1091365 Kit, Circuit, T-Piece Disposable, W MASK Size 1, 10 pack

The T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation
units may impact patient safety. The issue occurs when the T-piece circuit is
not able to achieve maximum PIP (Peak Inspiratory Pressure) of 45 +/- 5
cmH[2]O as measured by the built-in Airway Pressure Manometer during the
pre-use checkout procedure. The built-in Airway Pressure Manometer of the
resuscitation system is not affected by this issue and will accurately display
airway pressure. Clinicians should always use the airway pressure manometer to
verify Peak Inspiratory Pressure (PIP). The affected units were manufactured
from September 10, 2009 to May 10, 2012.

GE Healthcare initiated the field correction on June 26, 2012, and began
notifying customers with affected units through an Urgent Medical Device
Correction letter and follow up has been conducted to confirm their receipt of
the letter. Through these efforts, approximately 84% of identified customers
have confirmed receipt of the safety instructions provided and have also
confirmed all affected product has been returned or destroyed. The remaining
unconfirmed customers are being contacted directly to resolve and close the
issue as soon as possible. Customers have been directed to NOT use the T-piece
circuit with the part numbers listed above and to isolate all affected
product. To date, no patient injuries have been reported with this issue.

The U.S. Food and Drug Administration (FDA) has classified this recall as a
Class I recall. FDA defines Class I recalls as “a situation in which there is
a reasonable probability that the use of or exposure to the violative product
will cause serious adverse health consequences or death.”

For additional information regarding this field correction or to arrange
return and/or replacement of the product, please contact GE Healthcare
Customer Service at 1-800-345-2700.

Contact:

GE Healthcare
Annette Busateri, +1-262-442-0966
annette.busateri@ge.com
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