BEUDAMED
    FDA Enforcement Class II Terminated

    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH

    Recall: Z-1359-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1359-2015
    Event ID
    70683
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 5, 2015
    Classification Date
    April 1, 2015
    Termination Date
    August 25, 2016
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH

    Reason

    Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.

    Code Info

    Brilliance iCT: 728306; Serial Numbers: 85012, 85013, 85014, 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100512, 100517 & 100518. Brilliance iCT SP: 728311; Serial Numbers: 200047 & 200121. Ingenuity Core: 728321; Serial Numbers: 31001, 52007, 52008, 52010, 52012, 52013, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52042, 52043, 52046, 52052, 52053, 52054, 52055, 52057, 52058, 310001, 310002, 310003, 310009, 310017, 310052, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310096, 310111, 310113, 310119, 310121, 310129, 310133, 310134, 310141, 310143, 310144, 310149, 310151, 310157, 310160, 310170, 333002, 333009, 333014, 333015, 333030, 333031, 333037, 333042, 333043, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333056, 333057, 333059, 333060 & 333061. Ingenuity Core128: 728323; Serial Numbers: 32010, 32013, 32015, 32016, 32018, 32021, 32024, 32026, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32055, 32057, 32059, 32060, 32062, 32064, 32065, 32067, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32080, 32082, 32083, 32084, 32085, 32087, 32089, 32090, 32091, 32092, 32094, 32095, 32100, 32101, 32103, 32104, 32106, 300137, 320003, 320005, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320054, 320069, 320073, 320074, 320078, 320079, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320129, 320131, 320132, 320133, 320134, 320138, 320144, 320146, 320147, 336011, 336012, 336013, 336016, 336018, 336028, 336029, 336034, 336044, 336046, 336059, 336061, 336064, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336073, 336075, 336076, 336077, 336078, 336080, 336082, 336083, 336086, 336087, 336088, 336089, 336090 & 336092. Ingenuity CT: 728326; Serial Numbers: 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30011, 30012, 30013, 30015, 30018, 30019, 30020, 30025, 32086, 32093, 32107, 52023, 52044, 52051, 300003, 300004, 300005, 300010, 300011, 300012, 300013, 300014, 300016, 300017, 300019, 300020, 300021, 300024, 300025, 300027, 300028, 300029, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300047, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300110, 300111, 300112, 300113, 300114, 300115, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300135, 300136, 300139, 300140, 300142, 300143, 300144, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 310058 & 30004.

    Distribution

    Worldwide Distribution - Nationwide Distribution to the states of : AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV and WY., and to the countries of : Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Cambodia, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jumeirah, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Training, Tunisia, Turkey, United Arab Emirates,United Kingdom, Uzbekistan and Viet Nam.

    Quantity

    424 units