Events

Rappel de Device Recall Brilliance Workspace Portal

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 (Cleveland) Inc.

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
    61250
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1219-2012
  • Date de mise en oeuvre de l'événement
    2012-02-23
  • Date de publication de l'événement
    2012-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107661
  • 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
    System, tomography, computed, emission - Product Code KPS
  • Cause
    Incorrect standardized uptake value ("suv") values are displayed in two instances: 1. after loading pet data (with a slope value different than 1) into the quick review (qr) application from a remote device; and 2. during the loading the above mentioned type of pet data into the ct viewer application from a remote device.
  • Action
    The Philips Healthcare, sent an "URGENT-Medical Device Correction" Field Safety Notice dated February 08, 2012 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of their staff and to retain a copy with the equipment Instruction for Use. The letter notifies the customers that a Field Service Engineer will be contacting them to schedule a visit to implement the corrective action by installing the software update version 2.6.1. If you need further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Device

Device Recall Brilliance Workspace Portal
  • Modèle / numéro de série
    Model #: 728269; Serial #s: 79901, 79902, 79903, 79904, 79905, 79906, 79907, 79910, 79911, 79912, 79913, 79914, 79916, 79917, 79918, 79920, 79921, 79922, 79923, 79924, 79925, 79926, 79927, 79928, 79929, 79930, 79931, 79932, 79934, 79935, 79936, 79937, 79939, 79940, 79942, 79943, 79944, 79945, 80002, 80005, 80006, 80007, 80009, 80010, 80011, 80025, 80026, 80027, 80031, 80032, 80037, 80039, 80040, 80041, 80042, 80047, 80053, 80054, 80056, 80058, 80059, 80060, 80061, 80062, 80063, 80065, 80066, 80067, 80068, 80069, 80070, 80071, 80072, 80073, 80075, 80076, 80077, 80078, 80079, 80080, 80081, 80082, 80084, 80085, 80086, 80087, 80088, 80091, 80093, 80094, 80095, 80096, 80097, 80098, 80109, 80110, 80111, 80112, 80113, 80114, 80115, 80116, 80117, 80119, 80121, 80123, 80128, 80129, 80130, 80133, 80134, 80137, 80139, 80140, 80141, 80143, 80145, 80146, 80147, 80148, 80149, 80150, 80151, 80152, 80153, 80154, 80155, 80156, 80157, 80158, 80160, 80161, 80162, 80163, 80164, 80165, 80166, 80167, 80168, 80169, 80170, 80171, 80172, 80173, 80174, 80175, 80176, 80177, 80178, 80179, 80180, 80181, 80182, 80183, 80186, 80189, 80190, 80191, 80192, 80193, 80194, 80195, 80198, 80199, 80200, 80201, 80202, 80203, 80204, 80205, 80206, 80207, 80208, 80209, 80210, 80211, 80212, 80213, 80214, 80215, 80216, 80217, 80218, 80219, 80223, 80224, 80226, 80227, 80228, 80229, 80230, 80231, 80232, 80233, 80234, 80237, 80238, 80239, 80240, 80242, 80243, 80244, 80245, 80246, 80247, 80248, 80249, 80250, 80251, 80252, 80253, 80254, 80255, 80256, 80257, 80258, 80259, 80260, 80261, 80262, 80263, 80264, 80265, 80266, 80268, 80269, 80270, 80271, 80272, 80273, 80274, 80275, 80276, 80277, 80278, 80279, 80280, 80281, 80282, 80283, 80284, 80285, 80286, 80287, 80288, 80289, 80290, 80291, 80292, 80293, 80294, 80295, 80296, 80297, 80298, 80299, 80300, 80301, 80302, 80303, 80305, 80306, 80308, 80309, 80312, 80313, 80314, 80315, 80316, 80317, 80318, 80320, 80322, 80323, 80324, 80325, 80326, 80327, 80328, 80329, 80330, 80331, 80332, 80333, 80334, 80335, 80336, 80337, 80339, 80340, 80341, 80344, 80345, 80346, 80347, 80348, 80349, 80350, 80353, 80354, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80377, 80378, 80379, 80380, 80381, 80382, 80383, 80384, 80385, 80386, 80387, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80396, 80397, 80398, 80399, 80401, 80402, 80406, 80409, 80410, 80416, 80417, 80418, 80419, 80420, 80421, 80422, 80423, 80424, 80425, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80435, 80436, 80437, 80438, 80439, 80440, 80442, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 80459, 80460, 80461, 80462, 80463, 80464, 80466, 80467, 80470, 80471, 80472, 80473, 80474, 80475, 80476, 80477, 80479, 80480, 80481, 80482, 80483, 80484, 80485, 80486, 80487, 80488, 80489, 80491, 80492, 80493, 80494, 80495, 80496, 80497, 80502, 80503, 80504, 80505, 80506, 80507, 80508, 80509, 80510, 80514, 80515, 80516, 80517, 80518, 80519, 80520, 80521, 80526, 80527, 80529, 80536, 80537, 80538, 80539, 80540, 80541, 80542, 80543, 80544, 80546, 80547, 80548, 80551, 80552, 80553, 80554, 80555, 80556, 80557, 80558, 80559, 80560, 80561, 80562, 80566, 80567, 80568, 80569, 80570, 80571, 80572, 80573, 80574, 80575, 80576, 80577, 80578, 80579, 80580, 80581, 80582, 80583, 80584, 80585, 80586, 80587, 80588, 80589, 80591, 80592, 80593, 80594, 80595, 80596, 80597, 80598, 80599, 80600, 80601, 80602, 80603, 80604, 80605, 80608, 80609, 80610, 80611, 80612, 80613, 80614, 80615, 80616, 80617, 80618, 80619, 80620, 80621, 80622, 80623, 80624, 80625, 80626, 80628, 80629, 80630, 80632, 80633, 80634, 80635, 80636, 80638, 80639, 80640, 80641, 80642, 80643, 80644, 80645, 80646, 80648, 80649, 80653, 80654, 80657, 80658, 80660, 80661, 80662, 80663, 80664, 80665, 80666, 80667, 80672, 80673, 80674, 80675, 80676, 80677, 80679, 80680, 80681, 80682, 80683, 80685, 80686, 80689, 80690, 80696, 80699, 80700, 80703, 80704, 80706, 80707, 80708, 80709, 80710, 80711, 80712, 80714, 80715, 80719, 80720, 80721, 80722, 80724, 80725, 80726, 80728, 80729, 80730, 80731, 80732, 80733, 80734, 80735, 80736, 80739, 80740, 80741, 80742, 80743, 80744, 80745, 80747, 80748, 80749, 80750, 80751, 80752, 80753, 80754, 80755, 80756, 80757, 80758, 80759, 80760, 80762, 80763, 80764, 80765, 80766, 80770, 80771, 80779, 80781, 80782, 80789, 80793, 80794, 80795, 80796, 80807, 80808, 80810, 80816, 80831, 80833, 80834, 80835, 80836, 80837, 80848, 80849, 80850, 80851, 80860, 80862, 80863, 80864, 80865, 80866, 80867, 80868, 80869, 80870, 80872, 80873, 80874, 80875, 80876, 80878, 80879, 80882, 80883, 80884, 80885, 80886, 80887, 80889, 80891, 80892, 80893, 80898, 80899, 80900, 80901, 80902, 80903, 80905, 80906, 80908, 80909, 80910, 80911, 80913, 80914, 80915, 80916, 80923, 80924, 80925, 80926, 80927, 80929, 80930, 80931, 80936, 80937, 80938, 80939, 80940, 80941, 80942, 80943, 80944, 80945, 80946, 80963, 80964, 80965, 80966, 80967, 80968, 80969, 80971, 80973, 80974, 80975, 80977, 80979, 80980, 80981, 80982, 80985, 80987, 80988, 80989, 80992, 80993, 80995, 80998, 80999, 81001, 81002, 81005, 81007, 81008, 81009, 81023, 81025, 81026, 81029, 81030, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81039, 81042, 81043, 81045, 81046, 81047, 81048, 81050, 81059, 81061, 81062, 81063, 81064, 81065, 81066, 81067, 81068, 81069, 81070, 81071, 81076, 81077, 81079, 81081, 81082, 81084, 81086, 81087, 81088, 81089, 81090, 81097, 81098, 81099, 81100, 81101, 81107, 81108, 81109, 81111, 81117, 81118, 81119, 81124, 81125, 81126, 81127, 81128, 81129, 81130, 81132, 81133, 81134, 81135, 81136, 81147, 81148, 81149, 81150, 81154, 81156, 81157, 81159, 81160, 81161, 81162, 81163, 81164, 81165, 85001, 85004.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distributions: USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, VA, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WI, and WV; and countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech, Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Poland, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Venezuela.
  • Description du dispositif
    The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. || The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA