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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 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 hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Recall Number Z-1547-2014
Classification Class II
Code Info HDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316
Product Distributed Qty 50 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.