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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description 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 arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Recall Number Z-1550-2014
Classification Class II
Code Info HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804
Product Distributed Qty 15 units
Reason For Recall 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.

Event Detail

Event Id 68067
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare
City Laurel
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution.