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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® 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 Number Z-1549-2014
Classification Class II
Code Info HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979
Product Distributed Qty 21 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.