Events

Retiro De Equipo (Recall) de Device Recall PCR Eleva

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Medical Systems North America Co. Phillips.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57558
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1019-2011
  • Fecha de inicio del evento
    2008-12-23
  • Fecha de publicación del evento
    2011-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96561
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Radiological Image Processing System - Product Code LLZ
  • Causa
    There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.
  • Acción
    On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees. The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected. The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue. All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference "FCO 73200029" with any questions.

Device

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, 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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
    Radiology Devices
  • 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
    Philips Medical Systems North America Co. Phillips

Manufacturer

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