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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® 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 arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Recall Number Z-1548-2014
Classification Class II
Code Info HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705 HDJR57706 HDJR57707 HDJR57784 HDJR57785 HDJR57786 HDJR57787 HDJR57788 HDJR57789 HDJR57790 HDJR57791 HDJR57792 HDJR57793 HDJR57794 HDJR57795 HDJR57925 HDJR57926 HDJR57935 HDJR57936 HDJR57937 HDJR57938 HDJR57939 HDJR57944 HDJR57948 HDJR57949 HDJR57950 HDJR57951 HDJR57952 HDJR57953 HDJR57954 HDJR57955 HDJR57956 HDJR57957 HDJR57980 HDJR57981 HDJR57985 HDJR57986 HDJR57987 HDJR57988 HDJR58013 HDJR58014 HDJR58015 HDJR58039 HDJR58040 HDJR58041 HDJR58046 HDJR58047 HDJR58076 HDJR58082 HDJR58086 HDJR58087 HDJR58088 HDJR58091 HDJR58092 HDJR58093 HDJR58094 HDJR58095 HDJR58096 HDJR58097 HDJR58098 HDJR58099 HDJR58100 HDJR58101 HDJR58102 HDJR58103 HDJR58104 HDJR58105 HDJR58106 HDJR58107 HDJR58108 HDJR58109 HDJR58110 HDJR58111 HDJR58112 HDJR58113 HDJR58114 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Product Distributed Qty 723 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.