Events

Rappel de Device Recall PCR Eleva

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Co. Phillips.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57558
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1019-2011
  • Date de mise en oeuvre de l'événement
    2008-12-23
  • Date de publication de l'événement
    2011-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96561
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Radiological Image Processing System - Product Code LLZ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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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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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA