Rappel de Device Recall Brightview

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76483
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1480-2017
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • Date de publication de l'événement
    2017-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    diagnostic scanner - Product Code KPS
  • Cause
    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.
  • Action
    Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.

Device

  • Modèle / numéro de série
    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,
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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).
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
  • Source
    USFDA