Device Recall Philips

Software versions A.02.00 and lower

Cardiovascular Devices

3

No

Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen

Philips Heartstart MRx Monitor/Defibrillator || Models: M3535A (Hospital Use) , M3536A (EMS Use)

M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial number prefix DE441 and DE512 and MMS software revision C.0 or B.1

Anesthesiology Devices

2

No

Worldwide, including USA, Canada, Argentina, Australia, Austria, Belgium, Brazil, Czech, Croatia, China, Denmark, Finland, France, Germany, Israel, Italy, Jordan, Kuwait, Luxemburg, Netherlands, Oman, Norway, Poland, Portugual, Poland, Russia, South Africa, Spain, Sweden, Swizerland, Turkey, UAE, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.

IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. || Model: M3001A

Serial Numbers affected: 1204137082, 1204137014, 1204137016, 1204137022, 1204137126, 1204137128, 1204137132, 1204137136, 1204137146, 1204137018, 1204137020, 1204137124, 1204137130, 1204137134, 1204137138, 1204137028, 1204137030, 1204137032, 1204137036, 1204137038, 1204137040, 1204137042, 1204137044, 1204137046, 1204137048, 1204137050, 1204137064, 1204137070, 1204137072, 1204137074, 1204137076, 1204137078, 1204137080, 1204137084, 1204137086, 1204137088, 1204137090, 1204137092, 1204137094, 1204137140, 1204137162, 1204137164, 1204137166, 1204137168, 1204137196, 1204137198, 1204137200, 1204137202, 1204137204, 1204137206, 1204137208, 1204137034, 1204137144, 1204137142, 1204137228, 1204137396, 1204137054, 1204137056, 1204137058, 1204137060, 1204137062, 1204137066, 1204137068, 1204137096, 1204137100, 1204137102, 1204137104, 1204137106, 1204137108, 1204137110, 1204137112, 1204137114, 1204137116, 1204137118, 1204137226, 1204137230, 1204137238, 1204137266, 1204137268, 1204137270, 1204137272, 1204137286, 1204137290, 1204137294, 1204137120, 1204137122, 1204137224, 1204137232, 1204137234, 1204137236, 1204137274, 1204137276, 1204137280, 1204137282, 1204137284, 1204137288, 1204137292, 1204137296, 1204137298, 1204137300, 1204137304, 1204137306, 1204137308, 1204137312, 1204137316, 1204137318, 1204137322, 1204137324, 1204137330, 1204137354, 1204137388, 1204137394, 1204137572, 1204137352, 1204137386, 1204137382, 1204137384, 1204137472, 1204137483, 1204137381, 1204137302, 1204137310, 1204137314, 1204137334, 1204137336, 1204137338, 1204137340, 1204137342, 1204137344, 1204137346, 1204137356, 1204137358, 1204137360, 1204137362, 1204137364, 1204137374, 1204137376, 1204137379, 1204137389, 1204137390, 1204137392, 1204137398, 1204137400, 1204137402, 1204137403, 1204137404, 1204137406, 1204137408, 1204137409, 1204137410, 1204137411, 1204137412, 1204137414, 1204137416, 1204137418, 1204137420, 1204137421, 1204137424, 1204137427, 1204137429, 1204137433, 1204137435, 1204137438, 1204137442, 1204137448, 1204137450, 1204137454, 1204137456, 1204137458, 1204137460, 1204137464, 1204137468, 1204137477, 1204137481, 1204137485, 1204137487, 1204137489, 1204137320, 1204137326, 1204137332, 1204137348, 1204137350, 1204137366, 1204137368, 1204137370, 1204137372, 1204137378, 1204137383, 1204137385, 1204137387, 1204137391, 1204137395, 1204137397, 1204137399, 1204137401, 1204137405, 1204137413, 1204137415, 1204137417, 1204137419, 1204137422, 1204137423, 1204137431, 1204137436, 1204137437, 1204137439, 1204137440, 1204137446, 1204137452, 1204137462, 1204137466, 1204137470, 1204137474, 1204137476, 1204137478, 1204137479, 1204137480, 1204137482, 1204137484, 1204137486, 1204137488, 1204137491, 1204137493, 1204137495, 1204137497, 1204137499, 1204137501, 1204137503, 1204137505, 1204137507, 1204137509, 1204137511, 1204137524, 1204137526, 1204137528, 1204137530, 1204137532, 1204137534, 1204137536, 1204137538, 1204137564, 1204137568, 1204137570, 1204137576, 1204137578, 1204137580, 1204137582, 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Cardiovascular Devices

3

No

Distribution is worldwide.

HeartStart FR2+ Defibrillator

Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546

Cardiovascular Devices

2

No

Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Philips SureSigns VM Series Patient Monitors: || VM4, VM6, VM 8: || Model Part Numbers || VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 || VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 || VM8 863066, 863068, 453564022081, 453564024461, 453564024481 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999

Cardiovascular Devices

2

No

Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Philips SureSigns VS3 Vital Signs Monitor Models: || VS3 863069, 863070, 453564041251, 453564041261, || VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.