Device Recall MultiDiagnost Eleva

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    505039, 104530, 506247, 102666, 104136, 104838, 506155, 105194.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Philips Medical Systems North American Company distributes product to medical facilities nationwide.
  • Product Description
    MultiDiagnost Eleva || Part Numbers: 9896 001 41501 and 9896 001 41502
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    MultiDiagnost Eleva
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
  • Product Description
    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
  • Model / Serial
    Site numbers: 41783749, 42892425, 43386703, 43453378, and 42799914.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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