Skip to content
Recall Observatory FDA recall evidence

Device product

Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Z-0697-2017

November 12, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 75756
Status
Terminated
Classification
Class II
Quantity
371
Official record key
device-enforcement:Z-0697-2017

Official wording

Reason: Software error due to the filament on timer

Code information: 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 30047, 30048, 30049, 32045, 32083, 32107, 52051, 52060, 52062, 300003, 300004, 300005, 300009, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300022, 300024, 300025, 300027, 300028, 300029, 300030, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300047, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300064, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300083, 300084, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300115, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300133, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300220, 300221, 300222, 300223, 300224, 300225, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 310058, 310144, 320205, 333057, 333084, 333128, 336061, 336084, 336121, 30004-1, 52082, 52083, 310251, 310317, 310319, 310321, 310322, 310323, 310324, 310325, 310326, 310327, 310330, 310331, 333137, 333140, 333144, 333146, 333150, 333151, 320259, 320281, 320285, 320288, 320289, 320290, 320291, 320292, 320293, 320295, 320296, 320297, 320299, 320302, 320303, 320305, 320309, 336218, 336219, 336222, 336229, 336234, 336236, 336241, 336246, 336249, 336252, 336256, 336781, 336782, 336783, 336784, 336785, 336786, 336787, 336788, 336789, 336790, 336791, 300219, 52080, 52084, 310019, 310244, 310268, 310298, 310302, 310305, 310306, 310307, 310309, 310310, 310314, 310322, 310334, 310335, 310338, 310339, 310340, 333120, 333126, 333127, 333130, 333131, 333132, 333138, 333139, 333141, 333142, 333143, 333148, 333152, 333153, 333154, 32022, 32171, 320277, 320294, 320300, 320304, 320306, 320308, 320314, 320315, 320316, 320317, 320318, 320319, 320320, 320321, 320322, 320323, 320324, 320325, 320326, 320327, 320328, 320329, 320331, 320332, 320335, 336237, 336238, 336239, 336240, 336242, 336244, 336250, 336251, 336253, 336254, 336255, 336258, 336264, 336266, 600023, 600047, 941192, 941200, 941204 and 941206.

Distribution pattern: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software error