Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-1359-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: February 5, 2015

Date Posted: April 8, 2015

Recall Number: Z-1359-2015

Event ID: 70683

Reason for Recall:

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.

Status: Terminated

Product Quantity: 424 units

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated