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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance Workspace Portal

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 Class 2 Recall
Brilliance Workspace Portal
see related information
Date Posted March 16, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-1219-2012
Recall Event ID 61250
Premarket Notification
510(K) Number
K000908 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact Joseph Vinhais
800-722-9377
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
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).
Quantity in Commerce 822
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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