CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report

Brilliance iCT and Brilliance iCT SP These systems recalled

Philips Medical Systems (Cleveland) is recalling Brilliance iCT and Brilliance iCT SP These systems are intended to produce, distributed nationwide in the US. The recall was initiated on 16 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # 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.

Quantity recalled506

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0831-2014
FDA event ID: 66197
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2013
FDA classified: 27 Jan 2014
Reported: 5 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

16 Jul 2013	Recall initiated by company
27 Jan 2014	Classified by FDA	+195 days
5 Feb 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An artifact that resembles thrombus may appear on the image.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California District of Columbia Delaware Florida Georgia Iowa Illinois Indiana Kentucky Massachusetts Maryland Minnesota Missouri Mississippi North Carolina Nevada New York

Questions about this recall

Why was it recalled?

An artifact that resembles thrombus may appear on the image.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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