Safety Enforcement Notice

Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Issued for products by Philips Medical Systems

Recall Event Details

Primary ID / Event Code: Z-0012-2017
Classification Code: 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, 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, 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, 300146, 600023, 600047, 300215, 300216, 300217, 300218, 300219, 300220, 300221, 300223, 310058, 310144, 320205, 333057, 333084, 333128, 336061, 336084, 336121, 336233, 30004-1
Manufacturer: Philips Medical Systems
Reported Date: August 9, 2026