Device product
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
Z-1481-2013
Product summary
- Event
- Event 65140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 505 units
- Official record key
device-enforcement:Z-1481-2013
Official wording
Reason: Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
Code information: Model # 882480, Serial #'s: 400054,400381, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000098, 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, 4000136, 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, 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, 4000282, 4000283, 4000284, 4000285, 4000287, 4000289, 4000290, 4000291, 4000292, 4000293, 4000295, 4000296, 4000297, 4000298, 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, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000485, 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, 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, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000609, 4000610, 4000611, 4000614, 4000614, 4000616, 4000620, 4000621, 4000623, 4000636, 4340004, 40000092, 0000101, 41443714, 49544434, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000103-4000151-1,4000223-1, 4000246A, 4000301-1, 4000472A & 4000484A.
Distribution pattern: Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.
Derived failure modes
-
Unknown
Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.