BEUDAMED
    FDA Enforcement Class II Terminated

    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 of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    Recall: Z-1549-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1549-2014
    Event ID
    68067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    April 2, 2014
    Classification Date
    May 6, 2014
    Termination Date
    May 11, 2016
    Address
    8880 Gorman Rd, N/A, Laurel, MD, 20723-5800, United States

    Description

    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 of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    Reason

    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.

    Code Info

    HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979

    Distribution

    Worldwide Distribution.

    Quantity

    21 units