Safety Enforcement Notice

Ingenuity Core Model Number 728321 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-0010-2017
Classification Code: 30041, 31001, 33084, 52000, 52004, 52007, 52008, 52010, 52012, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52022, 52024, 52025, 52026, 52027, 52029, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52040, 52041, 52042, 52043, 52044, 52045, 52046, 52047, 52048, 52050, 25052, 52053, 52054, 52055, 52056, 52057, 52058, 52059, 52061, 52063, 52064, 52065, 52067, 52068, 52069, 52070, 52071, 52072, 52073, 52074, 52075, 52076, 52077, 52078, 52079, 52080, 52081, 52082, 52083, 52084, 132164, 132465, 310001, 310002, 310003, 310009, 310017, 310019, 310022, 310023, 310026, 310032, 310039, 310042, 310052, 310054, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310090, 310096, 310098, 310105, 310107, 310111, 310113, 310116, 310119, 310121, 310125, 310129, 310133, 310134, 310135, 310141, 310143, 310149, 310150, 310151, 310157, 310159, 310160, 310170, 310203, 310204, 310205, 310206, 310207, 310208, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310244, 310245, 310246, 310247, 310248, 310249, 310250, 310251, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310268, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310297, 310298, 310299, 310300, 310301, 310302, 310303, 310304, 310305, 310306, 310307, 310308, 310309, 310310, 310311, 310313, 310315, 310316, 310317, 310318, 310319, 310320, 310321, 310322, 310323, 310324, 310325, 310326, 310327, 310328, 310329, 310330, 310331, 333002, 333005, 333009, 333010, 333014, 333015, 333018, 333019, 333021, 333030, 333031, 333037, 333041, 333042, 333043, 333044, 333045, 333046, 333048, 333049, 333050, 333051, 333052, 333053, 333054, 333055, 333056, 333059, 333060, 333061, 333062, 333063, 333064, 333065, 333066, 333067, 333068, 333069, 333070, 333071, 333072, 333073, 333074, 333075, 333076, 333077, 333078, 333079, 333080, 333081, 333082, 333083, 333085, 333086, 333087, 333088, 333089, 333090, 333091, 333092, 333093, 333094, 333095, 333096, 333097, 333098, 333099, 333100, 333101, 333102, 333103, 333104, 333105, 333106, 333107, 333108, 333109, 333110, 333111, 333112, 333113, 333114, 333115, 333116, 333117, 333118, 333119, 333120, 333121, 333122, 333123, 333124, 333125, 333126, 333127, 333129, 333130, 333131, 333132, 333133, 333134, 333135, 333136, 333137, 333140, 333144, 333145, 333146, 333150, 333151
Manufacturer: Philips Medical Systems
Reported Date: August 9, 2026