The Recall Desk

FDA (Devices) recall action 68067

GE Healthcare recalled 5 products on 2014-05-14

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-05-14
Critical
0
Units
1,110

Why these products were recalled

Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··2014-05-14

    GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect

    GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-05-14

    GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.

    Product
    Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-05-14

    GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.

    Product
    Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arteri
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-05-14

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect

    GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-05-14

    GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect

    GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.

    Product
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology wi
    Category
    Distribution
    0 states