Device Recall Philips

  • 모델명 / 제조번호(시리얼번호)
    Allura Xper with release R8.2,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam
  • 제품 설명
    Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; || Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; || Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper FD20/15 OR Table, 722059
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 229 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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, 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0205140839, 0205140841, 0205140842, 0205140843, 0205140844, 0205140847, 0205140848, 0205140849, 0205140850, 0205140851, 0205140852, 0205140854, 0205140855, 0205140856, 0205140857, 0205140858, 0205140862, 0205140863, 0205140864, 0205140865, 0205140867, 0205140868, 0205140870, 0205140871, 0205140872, 0205140876, 0205140878, 0205140880, 0205140881, 0205140882, 0205140884, 0205140885, 0205140886, 0205140887, 0205140892, 0205140894, 0205140896, 0205140900, 0205140902, 0205140904, 0205140907, 0205140910, 0205140912, 0205140914, 0205140916, 0205140918, 0205140944, 0205140946, 0205140951, 0205140955, 0205140956, 0205140957, 0205140958, 0205140959, 0205140960, 0205140962, 0205140963, 0205140970, 0205140972, 0205140974, 0205140976, 0205140978, 0205140980, 0205140982, 0205140984, 0205140986, 0205140988, 0205140990, 0205140994, 0205140996, 0205140998, 0205141008, 0205141010, 0205141020, 0205140582, 0205140592, 0205140646, 0205140656, 0205140705, 0205140709, 0205140711, 0205140713, 0205140717, 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0205141210, 0205141258, 0205141268, 0205141277, 0205140829, 0205140936, 0205141012, 0205140845, 0205140967, 0205141086, 0205141092, 0205141093, 0205141104, 0205141106, 0205141115, 0205141125, 0205141132, 0205141209, 0205141221, 0205140802, 0205140837, 0205140861, 0205140981, 0205140983, 0205141002, 0205141014, 0205141047, 0205141069, 0205141070, 0205141073, 0205141079, 0205141103, 0205141109, 0205141113, 0205141120, 0205141121, 0205141142, 0205141199, 0205141213, 0205141246, 0205141275, 0205141279, 0205141084, 0205141117, 0205141201, 0205141236, 0205141240, 0205141281, 0205141283, 0205141285, 0205141291, 0205141262, 0205141226, 0205140934, 0205140995, 0205141001, 0205141060, 0205141064, 0205141074, 0205141137, 0205140992, 0205140809, 0205140905, 0205140977, 0205141037, 0205141143, 0205141155, 0205141299, 0205141015, 0205141027, 0205141078, 0205141175, 0205141238, 0205141287, 0205141033, 0205141215, 0205141264, 0205141017, 0205141256, 0205141040, 0205141085, 0205141043, 0205141054, 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0205141273, 0205141004, 0205141297, 0205141062, 0205141255, 0205140537, 0205141066, 0205141067, 0205141088, 0205141257, 0205141068, 0205141072, 0205140501, 0205141065, 0205141179, 0205141242, 0205141058, 0205140523, 0205140543, 0205140567, 0205141071, 0205141490, 0205141099, 0205141293, 0205141488, 0205141269, 0205141267, 0205141263, 0205141295, 0205141265, 0205141129, 0205142370, 0205142396, 0205142398, 0305143616, 0205140835, 0305143568, 0305143628, 0205141191, 0305143626, 0305143535, 0305143596, 0305143600, 0305143608, 0305143622, 0205141127, 0305143577, 0305143850, 0305143880, 0305143882, 0305143852, 0205140302, 0205141026, 0205141145, 0305143878, 0205140500, 0205140869, 0305143579, 0305143623, 0305143709, 0305143711, 0305143870, 0305144484, 0305144488, 0205141149, 0205140578, 0305144158, 0305144184, 0305144216, 0305144164, 0305144527, 0305144531, 0305144533, 0305143575, 0305144288, 0305144290, 0305144294, 0305144292, 0305146032, 0205141151, 0405149787, 0405149801, 0405149813, 0405149826, 0405150654, 0405150658, 0405150686, 0505152536, 0505152919, 1005170558, 0106179348, 0106179344, 0406191022.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distribution is worldwide.
  • 제품 설명
    HeartStart FR2+ Defibrillator
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
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