Device Recall MultiDiagnost Eleva

제조사

  • 제조사 주소
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.  708032 System Serial numbers 100, 198, 354, 104, 367, 68, 428, 183, 414, 355, 289, 32, 269, 361, 160, 423, 50, 56, 205, 350, 71, 208, 254, 108, 222, 286, 257, 253, 327, 128, 125, 40, 265, 174, 164, 214, 411, 263, 178, 103, 394, 425, 374, 284, 229, 79, 37, 11, 312, 116, 226, 296, 44, 49, 219, 207, 227, 154, 317, 18, 87, 406, 88, 244, 233, 315, 376, 288, 112, 402, 206, 261, 215, 31, 422, 344, 338, 342, 339, 384, 12, 136, 415, 416, 137, 228, 46, 126, 276, 280, 51, 193, 54, 232, 140, 20, 270, 121, 25, 59, 60, 48, 21, 28, 196, 199, 380, 316, 159, 153, 172, 14, 62, 216, 75, 282, 294, 340, 102, 76, 64, 13, 231, 106, 305, 372, 366, 364, 77, 189, 24, 279, 166, 221, 349, 72, 42, 424, 0, 80, 217, 43, 213, 197, 413, 145, 318, 210, 341, 111, 343, 55, 292, 241, 151, 246, 0, 110, 29, 141, 362, 35, 143, 236, 278, 99, 133, 365, 85, 267, 132, 134, 163, 127, 266, 412, 142, 144, 293, 358, 399, 303, 308, 238, 239, 287, 243, 74, 310, 34, 345, 39, 69, 409, 162, 240, 281, 368, 382, 357, 277, 26, 165, 224, 170, 171, 392, 237, 119, 30, 396, 36, 38, 211, 255, 53, 146, 188, 404, 41, 81, 256, 16, 130, 184, 115, 107, 247, 275, 373, 169, 192, 248, 388, 389, 147, 352, 397, 417, 209, 98, 245, 92, 203, 314, 297, 290, 353, 383, 86, 309, 363, 251, 235, 379, 129, 225, 260, 405, 90, 84, 249, 139, 120, 329, 161, 218, 201, 347, 66, 283, 122, 33, 113, 114, 268, 180, 181, 182, 105, 298, 299, 109, 124, 295, 258, 194, 73, 57, 91, 369, 259, 403, 152, 138, 400, 93, 157, 118, 89, 15, 220, 212, 401, 61, 67, 135, 47, 148, 65, 264, 346, 173, 407, 123, 375, 291, 52, 393, 306, 307, 398, 190.  708036 System serial numbers 19, 40, 21, 8, 9, 16, 45, 11, 17, 14, 30, 31, 32, 48, 12, 50, 4, 15, 25, 13, 18, 42, 46, 41, 36, 35, 37, 47, 27, 43, 10, 5, 7, 24, 34, 29, 26.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.
  • 제품 설명
    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    FCO 70800080 Equipment #'s 538440, 544123, 544904, 545156, 545198, 546578, 549417, 551519, 551714, 553287, 553435, 553838, 554283, 554284, 554633, 554640, 556197, 556369, 557258, 41444651, 41445097, 41445127, 41445131, 41445221, 41445237, 41445464, 41445652, 41445800, 41445927, 41455927, 41643223, 41783749, 41849575, 41954854, 42549980, 42799914, 42892004, 42892425, 43319037, 43386703, 43443091, 43453378, 43721197, 44146025, 44401636, and 44653739.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    MultiDiagnost Eleva
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    software version 4.3.1 or higher.  Units are identified with Site Numbers:  538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
  • 제품 설명
    Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher || Used for general R/F, fluoroscopy, radiography, and angiography examinations.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Site numbers: 41783749, 42892425, 43386703, 43453378, and 42799914.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
  • 제품 설명
    MultiDiagnost Eleva with FD. || The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications.
  • Manufacturer