Class 2 Device Recall BrightView XCT, BrightView X & BrightView SPECT

• Date Initiated by Firm: December 19, 2013
• Date Posted: February 24, 2014
• Recall Status: Terminated on January 12, 2015
• Recall Number: Z-1074-2014
• Recall Event ID: 67307
• 510(K)Number: K080927
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH.; ; Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
• Code Information: BrightView SPECT, Product code: 882480; Serial #'s: 400054, 4000002, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065, 4000066, 4000067, 4000068, 4000070, 4000071, 4000072, 4000073, 4000074, 4000075, 4000076, 4000077, 4000078, 4000079, 4000080, 4000081, 4000083, 4000086, 4000087, 4000088, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120, 4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000135, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000195, 4000196, 4000197, 4000198, 4000199, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000252, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278, 4000279, 4000280, 4000281, 4000282, 4000283, 4000284, 4000285, 4000287, 4000288, 4000289, 4000290, 4000291, 4000292, 4000293, 4000295, 4000296, 4000297, 4000298, 4000299, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 4000332, 4000333, 4000334, 4000335, 4000336, 4000337, 4000338, 4000339, 4000340, 4000341, 4000342, 4000343, 4000344, 4000345, 4000346, 4000347, 4000348, 4000349, 4000351, 4000352, 4000353, 4000354, 4000355, 4000356, 4000357, 4000358, 4000359, 4000360, 4000361, 4000362, 4000363, 4000364, 4000365, 4000366, 4000367, 4000368, 4000369, 4000370, 4000371, 4000372, 4000374, 4000375, 4000376, 4000377, 4000378, 4000379, 4000380, 4000381, 4000382, 4000383, 4000384, 4000385, 4000386, 4000387, 4000388, 4000389, 4000390, 4000391, 4000392, 4000394, 4000396, 4000397, 4000398, 4000399, 4000400, 4000401, 4000402, 4000403, 4000404, 4000405, 4000406, 4000407, 4000408, 4000410, 4000411, 4000412, 4000414, 4000415, 4000416, 4000417, 4000418, 4000419, 4000420, 4000421, 4000422, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000431, 4000432, 4000433, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000466, 4000467, 4000468, 4000469, 4000470, 4000473, 4000474, 4000475, 4000476, 4000477, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000485, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000508, 4000509, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541, 4000542, 4000543, 4000544, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000558, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000589, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000599, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000608, 4000609, 4000610, 4000611, 4000612, 4000614, 4000615, 4000616, 4000617, 4000619, 4000620, 4000621, 4000622, 4000623, 4000624, 4000625, 4000626, 4000627, 4000628, 4000629, 4000630, 4000631, 4000632, 4000633, 4000634, 4000635, 4000636, 4000638, 4000639, 4000640, 4000642, 4000643, 4000644, 4000645, 4000646, 4000647, 4000648, 4000649, 4000650, 4000653, 4000654, 4000655, 4000656, 4000657, 4000658, 4000659, 4000660, 4000661, 4000662, 4000663, 4000664, 4000666, 4000667, 4000668, 4000669, 4000670, 4000671, 4000672, 4000673, 4000674, 4000675, 4000676, 4000677, 4000678, 4000679, 4000680, 4000681, 4000682, 4000683, 4000684, 4000685, 4000686, 4000689, 4000690, 4000692, 4000693, 4000694, 4340004, 40000101, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000246A, 4000472A, 4000484A & TM1. BrightView X, Product code: 882478; Serial #'s: 11000003, 11000004, 11000005, 11000006, 11000008, 11000009, 11000011, 11000012, 11000013, 11000014, 11000015, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000028, 11000029, 11000030, 11000031, 11000033, 11000034, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000111, 11000112, 11000113, 11000115, 11000116, 11000117, 11000118, 11340002, 11340004 & 11340005. BrightView XCT, Product code: 882482; Serial #'s: 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000082, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000111, 6000112, 6000113, 6000114, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000122, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000163, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000243, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271, 6000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000282, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000301, 6000302, 6000303, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000340, 6000341, 6000342, 6000343, 6000344, 6000345, 6000346, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000374, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000391, 6000392, 6000393, 6000394, 6000395, 6000396, 6000398, 6000399, 6000400, 6000401, 6000402, 6000403, 6000404, 6000405, 6000407, 6000408, 6000409, 6000410, 6000411, 6000412, 6000413, 6000414, 6000415, 6000416, 6000417, 6000418, 6340008, 6340009, 6340010, 6340011, 11000021, 11000082, 6000004A & IBA_RSC, P01_8128.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Mrs. Kumudini J. Carter; 440-483-3032
• Manufacturer Reason for Recall: Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As
• FDA Determined Cause: Software design
• Action: On 12/19/2013 the firm sent Field Safety Notices to their customers.
• Quantity in Commerce: 1,143 units
• Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.