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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. 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). BS9SEN BS9SES BSAVX8 BSAVX9 BSAW3A BSAY0P BSAY0U BSAY15 BSAY18 BSAY1A BSAY1E BSAY1F BSAY1N BSAY1U BSAY1X BSAY3C BSAY3F BSAY3N BSAY3V BSAY3X BSAY5D BSAY5H BSAY8S BSAY9C BSAY9G BSAY9J BSAY9R BSAYAR BSAYAU BSAYB1 BSAYBW BSAYBX BSAYC3 BSAYC9 BSAYCB BSAYCC BSAYCD BSAYGV BSAYGX BSAYGY BSAYGZ BSAYH0 BSAYH4 BSAYH6 BSAYIG BSAYJC BSAYJD BSAYOW BSAYOZ BSAYPM BSAYPU BSAYR5 BSAYSA BSAYSJ BSB993 BSB9AG BSB9AJ BSB9AR BSB9AX BSB9B9 BSB9BD BSB9BE BSB9BK BSB9D6 BSB9D7 BSB9DB BSB9DE BSB9JK BSB9JU BSB9KG BSB9KU BSB9KY BSB9NW BSB9NX BSB9NY BSB9NZ BSB9P3 BSB9P6 BSB9PA BSB9PE BSB9PG BSB9PK BSB9PL BSB9PR BSB9PY BSB9R0 BSB9R3 BSB9R5 BSB9R7 BSB9R9 BSB9RC BSB9RL BSB9RY BSB9RZ BSB9S2 BSB9S3 BSB9S5 BSB9SJ BSB9SY BSB9SZ BSB9T4 BSB9T8 BSB9TA BSB9TD BSB9TG BSB9TJ BSB9TM BSB9TS bsb9tu BSB9TX BSB9TZ BSB9U1 BSB9X6 BSB9X7 BSB9X8 BSB9X9 BSB9XA BSB9XF BSB9XG BSB9XR BSB9XX BSB9Y6 BSB9Y7 BSB9YB BSBCUJ BSBCUS BSBCV1 BSBCV2 BSBCVB BSBCWP BSBOTA BSBOTE BSBOU2 BSBOU8 BSBPTL BSBXTL BSBXTT BSBXTX BSBXU1 BSBXUO BSCE5J BSCEC4 BSCEC5 BSCEC6 BSCEE5 BSCEEC BSCEED BSCEEF BSCEEH BSCEEJ BSCEEW BSCEHH BSCEHN BSCEHR BSCEHW BSCEHX BSCEHZ BSCEKP BSCEKT BSCEKV BSCM9V BSCMA8 BSCMA9 BSCMAD BSCZPT BSCZPU BSCZPW BSCZPY BSCZR6 BSCZR7 BSCZR9 BSCZRC BSCZRO BSCZRP BSCZRW BSD0B1 BSDOAK BSDOAT BSDOAU BSDOAY BSDOAZ BSEJGJ BSA41K BSAY0K BSAY21 BSAYA0 BSAYBC BSAYBH BSAYBN BSB9PX BSB9RR BSB9SB BSB9TH BSB9SA BSB9AV BSBCV5 BSCZRJ BSCZRY Class II 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. 301 units Z-1551-2014
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). HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804 Class II 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. 15 units Z-1550-2014
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). HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979 Class II 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. 21 units Z-1549-2014
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). 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HDJS51960 HDJS51961 HDJS51962 HDJS53441 HDJS53442 HDJS53461 HDJS51738 HDJS50473 HDJS50627 HDJS50631 HDJS50646 HDJS50647 HDJS50713 HDJS50714 HDJS50716 HDJS50719 HDJS50720 HDJS51151 HDJS53147 HDJS53148 HDJS53462 HDJS53463 HDJS53464 Class II 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. 723 units Z-1548-2014
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). 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 Class II 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. 50 units Z-1547-2014
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