The Recall Desk

FDA (Devices) recall action 63761

GE Healthcare, LLC recalled 2 products on 2013-02-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-02-20
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    Giraffe and Panda Bag and Mask 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.
    Category
    Distribution
    31 states
  • SevereFDA (Devices)··2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    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.
    Category
    Distribution
    31 states