Recalls / —

—#151166

Product

Ingenuity Core 128 728323

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K160743
Affected lot / code info: 30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32172, 52023, 52028, 52049, 52073, 320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211, 320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320253, 320254, 320255, 320256, 320257, 320258, 320260, 320261, 320262, 320263, 320264, 320265, 320266, 320267, 320268, 320269, 320270, 320271, 320272, 320273, 320274, 320275, 320276, 320277, 320278, 320279, 320280, 320282, 320283, 320284, 320286, 320287, 320294, 320298, 320301, 320307, 320310, 320311, 320312, 320313, 320330, 320334, 320336, 320338, 320339, 320340, 320341, 320343, 336011, 336012, 336013, 336015, 336016, 336017, 336018, 336023, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336046, 336051, 336059, 336060, 336064, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336073, 336075, 336076, 336077, 336078, 336079, 336080, 336081, 336082, 336083, 336085, 336086, 336087, 336088, 336089, 336090, 336091, 336092, 336093, 336094, 336095, 336096, 336097, 336098, 336099, 336100, 336101, 336102, 336103, 336104, 336105, 336106, 336107, 336108, 336109, 336110, 336111, 336112, 336113, 336114, 336115, 336116, 336117, 336118, 336119, 336120, 336122, 336123, 336124, 336125, 336126, 336127, 336128, 336129, 336130, 336131, 336132, 336133, 336134, 336135, 336136, 336137, 336138, 336139, 336140, 336141, 336142, 336143, 336144, 336145, 336146, 336147, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336165, 336166, 336167, 336168, 336169, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336179, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336187, 336188, 336189, 336190, 336191, 336192, 336193, 336194, 336195, 336196, 336197, 336198, 336199, 336200, 336201, 336202, 336203, 336204, 336205, 336206, 336207, 336208, 336209, 336210, 336211, 336212, 336213, 336214, 336215, 336216, 336217, 336220, 336221, 336223, 336224, 336225, 336226, 336227, 336228, 336230, 336231, 336232, 336233, 336235, 336243, 336245, 336247, 336248, 336257, 336259, 336260, 336261, 336262, 336263, 336265, 336267, 336268, 336269, 336270, 336271, 336272 and 336273.

Why it was recalled

Software error due to the filament on timer

Root cause (FDA determination)

Software design

Action the firm took

Philips sent a Customer Information Letter dated November 14, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2016-11-12
Terminated: 2019-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.