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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1480-2017

882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Publicado el 22 de marzo de 2017 · Inicio del retiro: 31 de enero de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Medical Systems (Cleveland) Inc
Distribuidor
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.
Lote
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, 4000
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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