FDAClass IIMarch 22, 2017

882480: BrightView designed for single or dual detector recall

882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform…

Why was 882480: BrightView designed for single or dual detector recalled?

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

4000201, 40007030003, 40007060006, 4000586, 4000327, 4000307, 4000361, 4000146, 4000159, 4000077, 4000050, 4000687, 4000325, 4000165, 4000252, 4000315, 4000191, 4000598, 4000141, 4000565, 4000135, 4000537, 4000591, 4000311, 4000626, 4000636, 4000329, 4000181, 4000644, 4000171, 4000120, 4000484A, 4000441, 4000054, 4000110, 4000653, 4000590, 4000100, 4000520, 4000323, 4000403, 4000406, 4000489, 4000277, 4000306, 4000332, 4000635, 4000270, 4000302, 4000046, 4000214, 4000615, 4000187, 4000660, 4000383, 4000633, 4000322, 4000212, 4000628, 4000034, 4000232, 4000668, 4000480, 4000430, 4000553, 4000467, 4000221, 4000127, 4000259, 4000670, 4000193, 4000222, 4000289, 4000597, 4000439, 4000542, 4000531, 4000588, 4000358, 4000330, 4000508, 4000310, 4000371, 4000501, 4000609, 4000616, 4000116, 4000452, 4000058, 4000521, 4000059, 4000064, 4000482, 4000384, 4000528, 4000177, 4000506, 4000278, 4000089, 4000139, 4000130, 4000564, 4000578, 4000674, 4000083, 4000583, 4000225, 4000267, 4000563, 4000587, 4000117, 4000053, 4000662, 4000526, 4000207, 4000118, 4000103, 4000556, 4000247, 4000326, 4000174, 4000248, 4000642, 4000696, 4000182, 4000456, 4000060, 4000522, 4000448, 4000099, 4000246, 4000175, 4000524, 4000630, 4000155, 4000367, 4000360, 4000492, 4000037, 4000230, 4000308, 4000236, 4000143, 4000285, 4000505, 4000206, 4000684, 4000164, 4000004, 4000650, 4000671, 4000473, 4000405, 4000235, 4000242, 4000680, 4000318, 4000561, 4000149, 4000073, 4000240, 4000606, 4000610, 4000304, 4000584, 4000580, 4000460, 4000263, 4000347, 4000632, 4000265, 4000368, 4000055, 4000349, 4000658, 4000351, 4000388, 4000589, 4000558, 4000106, 4000144, 4000444, 4000292, 4000098A, 4000319, 4000245, 4000295, 400054, 4000470, 4000666, 4000111, 4000148, 4000076, 4000443, 4000575, 4000654, 4000251, 4000108, 4000657, 4000659, 4000562, 4000535, 4000435, 4000357,4000677, 4000453, 4000377, 4000387, 4000446, 4000608, 40007060008, 4000036, 4000433, 4000538, 4000474, 4000414, 4000569, 4000266, 4000204, 4000119, 4000079, 4000234, 4000253, 4000192, 4000249, 4000634, 4000152, 4000380, 4000513, 4000198, 4000313, 4000340, 4000525, 4000541, 4000231, 4000424, 4000161, 4000170, 4000048, 4000239, 4000124, 4000200, 40007050005, 40007060007, 4000625, 4000264, 4000534, 4000261, 4000359, 4000220, 4000136, 4000140, 4000355, 4000087, 4000104, 4000611, 4000002, 4000040, 4000093, 4000258, 4000352, 4000291, 4000132, 4000334, 4000486, 4000271, 4000599, 4000605, 4000196, 4000363, 4000656, 4000362, 4000074, 4000577, 4000151-1, 4000238, 4000007, 4000113, 4000284, 4000260, 4000244, 4000391, 4000344, 4000695, 4000112, 4000205, 4000250, 4000052, 4000432, 4000275, 4000185, 4000646, 4000094, 4000215, 4000507, 4000090, 40000101, 4000582, 4000594, 4000128, 4000661, 4000431, 4000703001, 4000523, 4000078, 4000425, 4000062, 4000145, 4000011, 4000426, 4000440, 4000529, 4000450, 4000509, 4000241, 4000320, 40000092, 4000603, 4000496, 4000532, 4000502, 4000255, 4000593, 4000490, 4000293, 4000434, 4000619, 4000438, 4000095, 4000499, 4000623, 4000517, 4000624, 4000162, 4000402, 4000574, 4000476, 4000629, 4000649, 4000685, 4000596, 4000160, 4000546, 4000622, 4000186, 4000189, 4000445, 4000429, 4000274, 4000697, 4000673, 4000038, 4000176, 4000404, 4000114, 4000309, 4000138, 4000188, 4000369, 4000178, 4000459, 4000461, 4000468, 4000063, 4000150, 4000210, 4000217, 4000547, 4000527, 4000279, 4000208, 4000216, 4000269, 4000125, 4000254, 4000345, 4000415, 4000282, 4000449, 4000679, 4000199, 4000211, 4000331, 4000082, 4000134, 4000163, 4000373, 4000409, 4000465, 4000471, 4000545, 4000618, 4000637, 4000641, 4000153, 4000539, 4000663, 4000676, 4000477, 4000299, 4000133, 4000675, 4000314, 4000686, 4000209, 4000010, 4000621, 4000041, 4000167, 4000203, 4000407, 4000543, 4000374, 4000428, 4000157, 4000013, 4000075, 4000080, 4000086, 4000392, 4000396, 4000481, 4000689, 4000420, 4000690, 4000530, 4000639, 4000479, 4000568, 4000300, 4000572, 4000573, 4000640, 4000183, 4000142, 4000066, 4000226, 4000475, 4000519, 4000691, 4000645, 4000035, 4000219, 4000485, 4000643, 4000376, 4000416, 4000243, 4000437, 4000694, 4000551, 4340004, 4000272, 4000478, 4000296, 4000354, 4000493, 4000072, 4000237, 4000107, 4000227, 4000105, 4000698, 4000333, 4000339, 4000385, 4000109, 4000115, 4000356, 4000257, 4000173, 4000126, 4000121, 4000494, 4000398, 4000503, 4000386, 4000399, 4000179, 4000600, 4000400, 4000397, 4000194, 4000154, 4000504, 4000233, 4000256, 4000667, 4000401, 4000394, 4000585, 4000168, 4000631, 4000268, 4000382, 4000692, 4000693, 4000337, 4000595, 4000447, 4000273, 4000169, 4000442, 4000412, 4000488, 4000297, 4000228, 4000156, 4000047, 4000049, 4000096, 4000281, 4000288, 4000484, 4340005, 10422, 4000419, 4000462, 4000463, 4000464, 4000638, 4000390, 4000348, 4000613, 4000655, 4000286, 4000294, 4000395, 4000672, 4000057-OLD, 4000389, 4000290, 4000283, 4000312, 4000328, 4000375, 4000560, 4000366, 4000417, 4000051, 4000372, 4000151, 4000422, 4000195, 4000088, 4000381, 4000071, 4000003, 4000549, 4000487, 4000056, 4000006, 4000466, 4000550, 4000346, 4000683, 4000483, 4000301, 4000158, 4000223, 4000045, 4000129, 4000057, 4000557, 4000567, 4000370, 4000536, 4000029, 4000607, 4000067, 4000068, 4000032, 4000423, 4000039, 4000031, 4000620, 4000678, 4000601, 4000122, 4000647, 4000341, 4000316, 4000342, 4000408, 4000421, 4000495, 4000511, 4000664, 4000317, 4000338, 4000604, 4000682, 4000540, 4000137, 4000343, 4000030, 4000379, 4000451, 4000533, 4000602, 4000472A, 4000581, 4000469, 4000648, 4000510, 4000454, 4000335, 4000436, 4000353, 4000418, 4000491, 4000571, 4000197, 4000555, 4000518, 4000544, 4000500, 4000592, 4000617, 4000012, 4000213, 4000413, 4000699, 4000218, 4000123, 4000287, 4000070, 4000166, 4000202, 4000102, 4000276, 4000091, 4000301-1, 4000455, 4000033, 4000364, 4000008, 4000497, 4000498, 4000681, 4000009, 4000184, 4000554, 4000516, 4000303, 4000576, 4000190, 4000305, 4000411, 4000669, 4000614, 4000324, 4000612, 4000566, 4000627, 4000552, 4000280, 4000378, 4000336, 4000559, 4000229, 4000262, 4000298, 4000043, 400000275, 4000044, 4000065, 4000061, 4000180, 4000224, 4000321, 4000081, 4000410, 4000651, 4000652, 4000665, 4000688 & 5000916,

Product
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
1218 total
Distribution
Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls