Device Recall PCR Eleva

  • Modelo / Serial
    Site Numbers:  540174, 540902, 543457, 544694, 547848, 547849, 549554, 559966, 42047944, 42047945, 42047946, 42636410, 42636411, 42636457, 42785029, 44620447, 44620448, 44621161, 44892290, 45168464, 45311836, 506103, 44621154, 44621155, 541714, 538773, 539440, 541324, 541389, 541390, 541391, 541392, 541393, 544526, 545356, 42132637, 42132835, 42132836, 42132837, 42132841, 42799764, 42799768, 42799772, 42799784, 42799787, 42799822, 44038390, 44038393, 532267, 532268, 532269, 537619, 537627, 537633, 537650, 538445, 538505, 538506, 538507, 538508, 538701, 538702, 538979, 538980, 539061, 539430, 539431, 539432, 539433, 539434, 539436, 539437, 539438, 539439, 539441, 539442, 539443, 539449, 539450, 539451, 539452, 539453, 539619, 539664, 539740, 539741, 540294, 540352, 540357, 540358, 540359, 540360, 540369, 540428, 540429, 540430, 540489, 540496, 540637, 540966, 540997, 540998, 541035, 541066, 541240, 541252, 541254, 541255, 541307, 541326, 541346, 541349, 541398, 541399, 541400, 541437, 541616, 541618, 541713, 541826, 541828, 541829, 541889, 541893, 541901, 541902, 541904, 541909, 541915, 542108, 542164, 542165, 542166, 542167, 542168, 542169, 542170, 542188, 542189, 542190, 542246, 542247, 542249, 542254, 542377, 542383, 542410, 542600, 542639, 542640, 542641, 542642, 542665, 543413, 543414, 543416, 543417, 543418, 543419, 543421, 543424, 543603, 543604, 543605, 543606, 543612, 543613, 543614, 543615, 543631, 543632, 543693, 543719, 543758, 543825, 543830, 543831, 543927, 543940, 544089, 544115, 544194, 544281, 544381, 544588, 544592, 544595, 544685, 544686, 544688, 544689, 544690, 544691, 544875, 544940, 545015, 545016, 545054, 545055, 545263, 545287, 545352, 545353, 545354, 545361, 545362, 545363, 545364, 545379, 545380, 545381, 545430, 545431, 545566, 545567, 545825, 545845, 545886, 545887, 545892, 545893, 545908, 546003, 546167, 546168, 546169, 546170, 546171, 546172, 546173, 546174, 546175, 546483, 546484, 546485, 546486, 546487, 546488, 546489, 546619, 546678, 546690, 547179, 547412, 547670, 547672, 547702, 547829, 547830, 547831, 547847, 547863, 547868, 547869, 547883, 547964, 548106, 548109, 548256, 548257, 548259, 548325, 548327, 548328, 548578, 548623, 548748, 548750, 548774, 548856, 548857, 548858, 548987, 549111, 549256, 549266, 549267, 549268, 549324, 549351, 549377, 549388, 549529, 549530, 549647, 549710, 549821, 549870, 549898, 550042, 550043, 550090, 550114, 550115, 550134, 550135, 550266, 550267, 550268, 550269, 550270, 550272, 550273, 550274, 550275, 550295, 550296, 550305, 550320, 550335, 550341, 550342, 550386, 550816, 550817, 550929, 550938, 550939, 550958, 551002, 551003, 551018, 551276, 551343, 551354, 551356, 551411, 551419, 551430, 551432, 551438, 551439, 551440, 551442, 551509, 551520, 551521, 551542, 551672, 551839, 552076, 552083, 552119, 552120, 552144, 552145, 552174, 552212, 552213, 552253, 552254, 552400, 552415, 552443, 552521, 552522, 552654, 552655, 553053, 553120, 553209, 553210, 553291, 553331, 553332, 553333, 553334, 553335, 553338, 553339, 553386, 553388, 553444, 553641, 553643, 553721, 553901, 553927, 554091, 554095, 554325, 554404, 554405, 554406, 554445, 554446, 554530, 554531, 554532, 554533, 554534, 554535, 554536, 554537, 554538, 554558, 554582, 554595, 554613, 554616, 554617, 554618, 554623, 554624, 554625, 554626, 554627, 554632, 554657, 554718, 554795, 554796, 554800, 554801, 554857, 554876, 555017, 555121, 555270, 555385, 555386, 555388, 555389, 555390, 555408, 555476, 555522, 555665, 555666, 555697, 555709, 555745, 555782, 556018, 556090, 556091, 556133, 556163, 556164, 556175, 556176, 556178, 556179, 556233, 556519, 556551, 556665, 556793, 556837, 556843, 556860, 556864, 556869, 556957, 557023, 557162, 557164, 557285, 557286, 557287, 557288, 557350, 557571, 558415, 558421, 558516, 558517, 558518, 558519, 558520, 559769, 559941, 559942, 41443580, 41443588, 41443651, 41443724, 41443730, 41443733, 41443734, 41443736, 41443740, 41443780, 41443903, 41444566, 41444659, 41444757, 41445116, 41445143, 41445155, 41445331, 41445391, 41445406, 41445485, 41445586, 41445722, 41445738, 41445813, 41445824, 41445825, 41445831, 41445847, 41445858, 41445859, 41445861, 41445862, 41445867, 41445868, 41445869, 41445920, 41445926, 41445930, 41445932, 41446133, 41446318, 41541166, 41622509, 41704403, 41711727, 41747703, 41780360, 41781481, 41782214, 41782216, 41795153, 41796624, 41896219, 41938045, 42057214, 42057216, 42057217, 42066438, 42066439, 42066440, 42066441, 42122306, 42123337, 42248659, 42326712, 42373510, 42373516, 42392282, 42572848, 42573637, 42575723, 42608440, 42616791, 42681385, 42733785, 42824083, 42861599, 42865625, 42865626, 42865627, 42865628, 42866042, 42868067, 42868068, 42868069, 42869023, 42869024, 42869040, 42869090, 42869099, 42877564, 42892349, 42892350, 42892351, 42892352, 42975073, 42976502, 43016231, 43084789, 43191088, 43191785, 43209144, 43209145, 43209146, 43209147, 43209148, 43209149, 43209150, 43209151, 43209152, 43209153, 43209154, 43209155, 43273958, 43304526, 43394975, 43453755, 43453756, 43495013, 43504224, 43557517, 43645552, 43670905, 43691426, 43691427, 43691428, 43693170, 43693190, 43717665, 43718623, 43848154, 43860972, 43902585, 43902654, 43927326, 43959688, 43959689, 43959690, 44064829, 44216825, 44281797, 44328596, 44337100, 44469259, 44469264, 44488265, 44488344, 44500965, 44561177, 44561178, 44604134, 44615336, 44623917, 44642293, 44654099, 44706046, 44743559, 44781013, 44869929, 44869930, 44869931, 45074597, 45140095, 10386, 85175, 86027, 86028, 86029, 86030, 86239, 86240, 101892, 102832, 102935, 103769, 105172, 105354, 105400, 105401, 105701, 105709, 505051, 505716, 519108, 519109, 519110, 519111, 519112, 520407, 520408, 520528, 520672, 520673, 520704, 520931, 521891, 536615, 544490, 544491, 545888, 551834, 555510, 50159257, 50159268, 50159342, 551966, 539444, 505128, 544282, 553208, 43637238, and 43794689.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.
  • Descripción del producto
    PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". || Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA