Devices

Device Recall Philips

  • 모델명 / 제조번호(시리얼번호)
    This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM
  • 제품 설명
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
  • Manufacturer
    Philips Electronics North America Corporation
  • 1 Event

제조사

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

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Device Recall Philips Healthcare
  • 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
    Cardiovascular Devices
  • 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
    Philips Healthcare Inc.
Device Recall Philips Healthcare
  • 모델명 / 제조번호(시리얼번호)
    Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999
  • 의료기기 분류등급
    Cardiovascular Devices
  • 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
    Philips Healthcare Inc.
Device Recall Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWFIXED, 3/8"
  • 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
    Radiology Devices
  • 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
    Philips Medical Systems
Device Recall Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWTILT, 3/4"
  • 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
    Radiology Devices
  • 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
    Philips Medical Systems
Device Recall Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWTILT, 3/8"
  • 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
    Radiology Devices
  • 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, 3/8", Model Number: 4535-602-79811; || 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
    Philips Medical Systems
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