Philips

  • 모델명 / 제조번호(시리얼번호)
    Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit  M8040A option E22 Quick release kit for MP20MP30  A list of S/N's can be obtained fromthe recalling firm.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, Slovenia South Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia
  • 제품 설명
    Philips M8000-64100 Table Mount || Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. || Product shipped between 6/03/08 and 9/12/08 as follows: || M1013A IntelliVue G1 Gas Module || M1019A IntelliVue GS Gas Module || M8001A option E22 Quick release mount for IntelliVue MP20 || M8002A option E22 Quick release mount for IntelliVue MP30 || M8003A IntelliVue MP40 || M8004A IntelliVue MPSO || M8005A IntelliVue MP60 || M8007A IntelliVue MP70 || M8105A option E22 IntelliVue MP5 Quick Release Mount || M8105AT option E22 IntelliVue MPST Quick Release Mount || M8040A option U02 U02 Table top mount kit || M8040A option E22 Quick release kit for MP20MP30 || The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution:USA and Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Iceland, India, Ireland, Italy, Japan, Korea, Republic of Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Switzerland, Thailand, Trinidad, and Tobago, Ukraine, United Arab Emirates, United Kingdom.
  • 제품 설명
    HeartStart MRx Defibrillator Monitor, Model M3535A || HeartStart MRx Defibrillator Monitor, Model M3536A || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    DeviceSN: B10C-02133, B10C-02135, B10C-02136, B10C-02172, B10C-02196, B10C-02475, B10C-02477, B10C-02478, B10C-02480, B10C-02481, B10C-02494, B10C-02495, B10C-02499, B10C-02610, B10C-02631, B10C-02634, B10C-02639, B10C-02640, B10C-02641, B10C-02644, B10C-02645, B10C-02646, B10C-02647, B10C-02648, B10C-02651, B10C-02652, B10C-02653, B10C-02654, B10C-02655, B10C-02660, B10C-02674, B10C-02685, B10C-02702, B10C-02704, B10C-02705, B10C-02706, B10C-02707, B10C-02708, B10C-02709, B10C-02712, B10C-02713, B10C-02715, B10C-02717, B10C-02718, B10C-02719, B10C-02720, B10C-02721, B10C-02722, B10C-02723, B10C-02724, B10C-02725, B10C-02729, B10C-02732, B10C-02733, B10C-02734, B10C-02735, B10C-02736, B10C-02740, B10C-02742, B10C-02743, B10C-02744, B10C-02745, B10C-02746, B10C-02747, B10C-02749, B10C-02771, B10C-02779, B10C-02780, B10C-02781, B10C-02782, B10C-02783, B10C-02784, B10C-02785, B10C-02801, B10C-02805, B10C-02806, B10C-02816, B10C-02818, B10C-02822, B10C-02823, B10C-02824, B10C-02826, B10C-02830, B10C-02831, B10C-02832, B10C-02835, B10C-02836, B10C-02837, B10C-02838, B10C-02839, B10C-02840, B10C-02841, B10C-02843, B10C-02844, B10C-02845, B10C-02846, B10C-02847, B10C-02848, B10C-02849, B10C-02850, B10C-02851, B10C-02852, B10C-02853, B10C-02854, B10C-02855, B10C-02856, B10C-02858, B10C-02879, B10C-02881, B10C-02884, B10C-02886, B10C-02895, B10C-02896, B10C-02897, B10C-02900, B10C-02904, B10C-02905, B10C-02906, B10C-02907, B10C-02908, B10C-02909, B10C-02910, B10C-02911, B10C-02912, B10C-02913, B10C-02914, B10C-02915, B10C-02917, B10C-02919, B10C-02928, B10C-02929, B10C-02933, B10C-02937, B10C-02938, B10C-02943, B10C-02947, B10C-02948, B10C-02949, B10C-02950, B10C-02957, B10C-02965, B10C-03018, B10C-03019, B10C-03020, B10C-03021, B10C-03023, B10C-03024, B10C-03026, B10C-03040, B10C-03041, B10C-03042, B10C-03043, B10C-03045, B10C-03046, B10C-03047, B10C-03048, B10C-03049, B10C-03050, B10C-03119, B10C-03120, B10C-03121, B10C-03122, B10C-03123, B10C-03124, B10C-03125, B10C-03126, B10C-03127, B10C-03128, B10C-03156, B10C-03157, B10C-03158, B10C-03159, B10C-03160, B10C-03171, B10C-03175, B10C-03176, B10C-03178, B10C-03179, B10C-03180, B10C-03182, B10C-03194, B10C-03195, B10C-03196, B10C-03197, B10C-03198, B10C-03199, B10C-03200, B10C-03202, B10C-03203, B10C-03204, B10C-03205, B10C-03207, B10C-03208, B10C-03212, B10C-03213, B10C-03218, B10C-03247, B10C-03248, B10C-03251, B10C-03253, B10C-03255, B10C-03256, B10C-03257, B10C-03258, B10C-03259, B10C-03260, B10C-03262, B10C-03263, B10C-03265, B10C-03266, B10C-03267, B10C-03268, B10C-03269, B10C-03270, B10C-03271, B10C-03272, B10C-03273, B10C-03274, B10C-03275, B10C-03276, B10C-03286, B10C-03287, B10C-03288, B10C-03289, B10C-03290, B10C-03291, B10C-03292, B10C-03293, B10C-03295, B10C-03296, B10C-03297, B10C-03310, B10C-03329, B10C-03330, B10C-03332, B10C-03334, B10C-03335, B10C-03336, B10C-03338, B10C-03339, B10C-03340, B10C-03342, B10C-03349, B10C-03350, B10C-03355, B10C-03359, B10C-03360, B10C-03361, B10C-03362, B10C-03363, B10C-03364, B10C-03366, B10C-03367, B10C-03369, B10C-03384, B10C-03386, B10C-03437, B10C-03450, B10C-03451, B10C-03452, B10C-03453, B10C-03483, B10C-03484, B10C-03486, and B10C-03901.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • 제품 설명
    Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS--MODEL M5066A:  A10C-04048, A10C-04050, A10C-04300, A10C-04301, A10C-04302, A10C-04315, A10C-04316, A10C-04317, A10C-04318, A10C-04319, A10C-04320, A10C-04321, A10C-04322, A10C-04324, A10C-04325, A10C-04326, A10C-04327, A10C-04328, A10C-04330, A10C-04332, A10C-04333, A10C-04334, A10C-04335, A10C-04337, A10C-04338, A10C-04339, A10C-04340, A10C-04351, A10C-04352, A10C-04353, A10C-04354, A10C-04356, A10C-04357, A10C-04358, A10C-04359, A10C-04360, A10C-04361, A10C-04363, A10C-04364, A10C-04365, A10C-04366, A10C-04367, A10C-04368, A10C-04369, A10C-04611, A10C-04763, A10C-04812, A10C-04824, A10C-04824, A10C-05077, A10C-05078, A10C-05079, A10C-05080, A10C-05081, A10C-05083, A10C-05086, A10C-05087, A10C-05088, A10C-05089, A10C-05098, A10C-05151, A10C-05185, A10C-05191, A10C-05206, A10C-05207, A10C-05211, A10C-05212, A10C-05215, A10C-05216, A10C-05219, A10C-05233, A10C-05314, A10C-05315, A10C-05324, A10C-05397, A10C-05398, A10C-05429, A10C-05554, A10C-05569, A10C-05570, A10C-05571, A10C-05575, A10C-05578, A10C-05579, A10C-05580, A10C-05581, A10C-05583, A10C-05584, A10C-05585, A10C-05586, A10C-05587, A10C-05588, A10C-05591, A10C-05592, A10C-05593, A10C-05594, A10C-05595, A10C-05597, A10C-05599, A10C-05600, A10C-05751, A10C-05752, A10C-05759, A10C-05763, A10C-05764, A10C-05765, A10C-05767, A10C-05768, A10C-05769, A10C-05770, A10C-05771, A10C-05772, A10C-05775, A10C-05776, A10C-05777, A10C-05778, A10C-05779, A10C-05780, A10C-05781, A10C-05784, A10C-05785, A10C-05786, A10C-05787, A10C-05788, A10C-05789, A10C-05791, A10C-05792, A10C-05800, A10C-05913, A10C-05941, A10C-05968, A10C-05969, A10C-05970, A10C-05976, A10C-05977, A10C-05982, A10C-05983, A10C-06001, A10C-06002, A10C-06003, A10C-06006, A10C-06011, A10C-06013, A10C-06018, A10C-06020, A10C-06026, A10C-06027, A10C-06028, A10C-06354, A10C-06355, A10C-06356, A10C-06357, A10C-06358, A10C-06359, A10C-06360, A10C-06361, A10C-06364, A10C-06365, A10C-06366, A10C-06367, A10C-06368, A10C-06369, A10C-06370, A10C-06371, A10C-06372, A10C-06373, A10C-06374, A10C-06375, A10C-06376, A10C-06377, A10C-06378, A10C-06379, A10C-06381, A10C-06382, A10C-06383, A10C-06384, A10C-06385, A10C-06386, A10C-06387, A10C-06388, A10C-06390, A10C-06391, A10C-06392, A10C-06393, A10C-06394, A10C-06395, A10C-06396, A10C-06399, A10C-06400, A10C-06401, A10C-06402, A10C-06403, A10C-06404, A10C-06405, A10C-06406, A10C-06407, A10C-06408, A10C-06410, A10C-06411, A10C-06417, A10C-06418, A10C-06419, A10C-06420, A10C-06421, and A10C-06423.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • 제품 설명
    Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS--MODEL M5068A: A10C-05951.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • 제품 설명
    Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System || The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures
  • Manufacturer
하나 더 934 건 더