Events

Recall of Device Recall Brilliance Workspace Portal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61250
  • Event Risk Class
    Class 2
  • Event Number
    Z-1219-2012
  • Event Initiated Date
    2012-02-23
  • Event Date Posted
    2012-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107661
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    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
  • Model / Serial
    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, 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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, 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA