Device Recall Brilliance iCT and Brilliance iCT SP

Model # 728306 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100028, 100031, 100032, 100037, 100038, 100039, 100040, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100077, 100078, 100079, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100155, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100194, 100195, 100196, 100197, 100198, 100199, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100234, 100235, 100236, 100238, 100240, 100241, 100242, 100243, 100244, 100245, 100246, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100255, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100267, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100277, 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100293, 100294, 100295, 100296, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100310, 100311, 100312, 100313, 100314, 100315, 100316, 100317, 100318, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100329, 100330, 100331, 100332, 100333, 100334, 100335, 100336, 100337, 100338, 100339, 100340, 100341, 100342, 100343, 100344, 100345, 100346, 100347, 100348, 100349, 100350, 100351, 100352, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100363, 100364, 100365, 100366, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100384, 100385, 100386, 100387, 100388, 100389, 100391, 100392, 100393, 100394, 100395, 100396, 100397, 100398, 100399, 100400, 100401, 100402, 100403, 100404, 100405, 100406, 100407, 100408, 100409, 100410, 100411, 100412, 100413, 100414, 100415, 100416, 100417, 100418, 100423, 100424, 100426 and 100429. Model # 728311 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200014, 200015, 200016, 200017, 200018, 200019, 200020, 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200028, 200029, 200030, 200031, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200040, 200041, 200042, 200043, 200044, 200045, 200046, 200047, 200048, 200049, 200050, 200051, 200052, 200053, 200054, 200055, 200056, 200057, 200058, 200059, 200060, 200061, 200062, 200063, 200064, 200065, 200066, 200067, 200068, 200069, 200071, 200073, 200074, 200075, 200076, 200077, 200078, 200079, 200080, 200081, 200082, 200083, 200084, 200085, 200086, 200087, 200088, 200089, 200090, 200091, 200092, 200093, 200094, 200095, 200096, 200097, 200098, 200099, 200100, 200101, 200102, 200103, 200104, 200105, 200106, 200107, 200108, 200109, 200110, 200111, 200112, 200113, 200114, 200115, 200116, 200117, 200119, 200120, 200123, 200124, 200125 and 200126.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV., and the countries of Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.

Brilliance iCT and Brilliance iCT SP || These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories