—#149532

Product

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: 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

Why it was recalled

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

Root cause (FDA determination)

Software design

Action the firm took

Philips sent an Urgent Field Safety Notice (FSN) CLE 16-045 letter dated August 26, 2016, via a certified letter to customers. The letter identified the affected product, problem, actions to be taken by customer/user and actions planned by Philips to correct the problem. The letter informed customers a Philips field service representative will install a software update on the affected systems. For questions contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts)..

Recalling firm

Firm: Philips Medical Systems
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Timeline

Recall initiated: 2016-08-24
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149532. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.