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.
Enforcement
- Recall Number
- Z-1481-2013
- Event ID
- 65140
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2013
- Initiation Date
- April 25, 2013
- Classification Date
- June 5, 2013
- Termination Date
- February 12, 2014
- Address
- 595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States
Description
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.
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.
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.
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.
505 units