Computed Tomography X-ray Systems recall: Software Issue

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128…

Recalling firm

Philips Medical Systems (Cleveland) Inc

Quantity

424 units

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.

Recall date

April 8, 2015

Classification

Class II

Status

Terminated

Agency

FDA (device)