Events

Rappel de Device Recall BV25

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 Sales & Service Region No. America.

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
    29855
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1453-04
  • Date de mise en oeuvre de l'événement
    2004-07-20
  • Date de publication de l'événement
    2004-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-02-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34662
  • 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
    System, X-Ray, Mobile - Product Code IZL
  • Cause
    Potential for c-arm to move due to loose screws.
  • Action
    Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.

Device

Device Recall BV25
  • Modèle / numéro de série
    For all devices:  Part #s 980762000001, 980762000101, 980762010001, 980762010101, 980762020001, 980762020201, 984910000031, 984910000101, 989600006051, 989600006091, 989600006281, 989600006282, 989600007041, 989600007731  Site #s 59630, 104099, 101968, 101961, 101964, 59628, 59631, 59632, 101967, 101963, X1118, X1178, X1463, X1346, X1190, X1465, X0532, X1455, X1452, X1239, X1060, 300026, 300027, 13695, 10305, 13047, 13587, 13663, 35451, 13552, 15281, 13298, 13687, 14152, 13626, 15189, 13542, 15067, 10407, 13144, 15063, 14164, 13498, 13222, 13233, 13301, 15175, 13150, 82476, 15316, 13272, 5153, 13602, 15074, 14129, 15083, 13630, 82475, 13445, 10018, 15091, 59693, 13964, 13938, 13236, 4013, 6674, 6749, 59454, 6815, 6737, 6630, 6765, 6787, 81887, 6848, 5160, 6492, 4258, 6658, 6830,  6304, 101929, 6618, 6692, 6748, 4115, 6307, 6677, 4065, 4290, 6868, 6729, 4125, 6537, 6724, 6708, 4170, 6561, 76866, 5162, 5159, 4224, 6745, 5055, 6589, 34132, 34149, 35419, 38965, 35170, 34088, 34749, 34061, 35442, 34138, 34302, 34790, 67090, 61430, 34668, 504447, 35164, 35405, 81878, 34107, 34547, 34182, 34093, 41190, 61989, 31004, 34844, 34300, 35399, 34004, 31332, 67947, 35379, 35468, 16734, 17189, 17413, 17182, 16409, 17316, 16726, 16405, 16703, 41343, 41344, 16694, 17405, 16284, 16768, 16285, 16639, 17235, 17314, 17407, 16764, 16623, 17269, 16374, 16178, 17396, 17424, 17244, 16761, 16161, 17343, 16156, 16621, 16691, 16727, 17536, 16170, 17617, 17251, 17390, 16275, 61745, 17397, 17590, 81925, 16172, 61841, 17586, 76354, 16225, 16701, 17450, 17542, 16233, 17287, 17374, 16749, 16573, 16683, 17449, 17126, 16226, 16197, 17352, 16209, 16693, 17242, 17454, 17367, 17243, 17423, 62623, 62471, 61192, 17104, 17322, 17593, 17614, 76088, 17618, 76115, 17564, 16697, 10183, 17543, 87600, 76103, 17551, 37216, 76092, 17554, 16682, 76581, X0637, 17555, 76028, 17615, 76423, 16359, 16370, 40100, 17234, 17517, 17159, 16641, 16752, 16671, 16689, 16341, 16440, 16437, 17255, 16627, 16442, 16679, 86928, 76421, 76366, 76177, 76061, 17478, 17462, 17463, 86927, 76032, 67082, 17479, 17532, 76419, 76418, 17619, 17526, 100718, 17461, 76158, 76447, 76171, 6744, 76096, 76157, 6725, 76422, 76176, 76169, 76175, 76139, 17685, 84925, 16131, 16132, 17180, 16583, 17257, 16582, 17345, 16141, 16771, 13416, 15087, 16000, 13551, 17188, 13540, 16719, 16732, 17548, 17518, 82474, 16663, 17173, 16069, 16717, 16037, 16746, 16058, 16060, 17200, 17342, 16012, 16014, 17332, 16571, 17451, 16072, 59683, 17375, 16059, 16620, 16105, 82939, 17308, 16702, 16022, 17181, 16076, 16099, 59479, 84727, 13888, 13563, 13524, 13434, 13490, 13357, 10347, 13428, 13536, 10370, 13889, 13435, 15204, 13671, 13419, 10304, 13343, 13303, 13647, 15146, 44098, 10082, 13390, 10084, 10297, 82481, 84726, 15263, 15172, 15170, 59690, 13437, 10003, 15276, 13495, 13270, 15171, 10078, 19056, 62545, 61969, 19510, 38706, 62262, 61911, 38260, 61865, 19258, 19010, 62370, 19051, 62005, 62336, 19449, 62267, 68212, 84922, 19090, 19549, 62570, 62263, 61894, 19293, 62510, 62465, 62269, 61825, 62466, 61821, 61858, 14024, 104651, 19147, 62349, 6198, 6200, 6909, 76845, 76946, 6199, 6201, 6809, 6514, 10143, 104034, 13395, 6515, 44846, 6801, 6827, 6746, 6593, 59478, 6529, 6731, 6361, 84797, 6760, 6736, 6666, 25618, 6690, 6518, 6768, 6156, 6595, 10373, 15237, 13535, 15238, 13347, 10311, 13493, 43110, 13375, 15308, 10372, 15174, 10316, 13342, 10326, 13597, 15307, 13393, 10315, 13526, 10433, 15249, 13505, 13352, 13944, 13553, 15169, 10365, 13676, 10248, 13438, 13638, X1123, 505404, 504453, X1396, 81879, X1378, 84926, 81864, 84975, 81868, 81880, X0275, 81865, 84923, 81877, 250049, 84933, 81871, 250121, X1530, 59685, 250833, 81888, 250774, 250047, X0555, X1513, 250818, X1210, 37051, 37662, 37675, 37664, 37816, 37270, 37225, 37686, 37909, 37650, 38001, 37495, 37956, 37331, 37032, 37468, 37829, 37160, 37198, 37137, 37855, 37854, 37243, 37122, 37671, 37947, 37311, 37085, 37180, 37437, 37106, 43254, 37333, 37207, 37711, 37610, 37890, 100720, 37292, 37317, 38178, 37644, 37900, 37945, 37994, 37649, 38098, 59681, 35328, 59629, 34388, 34315, 35175, 34394, 34445, 35145, 41204, 35169, 34457, 35263, 35370, 35352, 41162, 34838, 35225, 31138, 35189, 35382, 35380, 35193, 31258, 100682, 34352, 41161, 41160, 35490, 37867, 62446, 37415, 37418, 37444, 37676, 37934, 37899, 37972, 37518, 37920, 37696, 37984, 37843, 504058, 37985, 37898, 37522, 37718, 37635, 37862, 37858, 37925, 37527, 37545, 83368, 37971, 37685, 38079, 37588, 37973, 37870, 37541, 37825, 37569, 37834, 37586, 37700, 37706, 37697, 37581, 37871, 37614, 37860, 37519, 37597, 37605, 37543, 37819, 37540, 37917, 37974, 37672, 37602, 37609, 37931, 37891, X0323, 35232, 34746, 35160, X0895, 35183, 34811, 35161, X1454, X0525, X0107, 104443, X1451, 38886, X1244, 104428, X1461, 35242, X1462, 34692, 35353, 31044, 35174, 31147, X0896, 104433, 31078, 90025, 35467, 34664, 31075, 31272, 35440, 81855, 35367, 34217, 31033, 80304, 31241, 34682, 35316, 35393, 34831, 35224, 34689, 82685, 41159, 31232, 31184, 31024, 31054, 31185, 31016, 31011, 31260, 35178, 59567, 34752, 31097, 31145, 31233, 35092, 31106, 35262, 31230, 31144, 41365, 31069, 31098, 37993, 34794, 41175, 31090, 34832, 104252, 504111, 504110, 35611, 35610, 41203, 41187, 82472, 41205, X0651, 105468, X1263, 105593, 104405, X0561, X0318, 104222, X0262, 104214, X0259, 104278, 506108, 104305, X0527, X0188, 104290, X1350, 506614, X0266, X0315, X0314, 104262, 104258, 104320, 104226, 37921, 37902, 37361, 37677, 37669, 37367, 37505, 37399, 38150, 35582, 38151, 37349, 37645, 37362, 37388, 37659, 37373, 25030, 25946, 25108, 25610, 47067, 25185, 25963, 25092, 25852, 25169, 25074, 25944, 25880, 38436, 26033, 25960, 59625, 25068, 84832, 25896, 25816, 25942, 25812, 26167, 38432, 25212, 25594, 25810, 25066, 25861, 26078, 26000, 82625, 59688, 25797, 26146, 25654, 25819, 28271, 26115, 25857, 25818, 26096, 25617, 26079, 26112, 25352, 25378, 25382, 25771, 40008, 25622, 25593, 49479, 25957, 25840, 25869, 25703, 28280, 28262, 4130, 25879, 28275, 19150, 25590, 31117, 40005, 67070, 26083, 25339, 26002, 25323, 40232, 25956, 25624, 25542, 505557, 28230, 25844, 25620, 46013, 26034, 25436, 26284, 28244, 61877, 25507, 25677, 25438, 25985, 26132, 26049, 37976, 25437, 14111, 25280, 28273, 25411, 25916, 25283, 25274, 25678, 26087, 25906, 84473, 25982, 25277, 37577, 25180, 25188, 25996, 28152, 40970, 28130, 26054, 28094, 28217, 25659, 26084, 28277, 28104, 26050, 25831, 28022, 25913, 25914, 26104, 26097, 38383, 31123, 25894, 26013, 28054, 504444, 250409, 250415, 250414, 250416, X0273, 250465, 250455, 84918, X0342, X0306, X0319, X0291, X1617, 250226, 504308, X0263, X0640, 250266, 504759, 505166, X1376, 250251, 250304, X1605, X0249, X0299, 13003, 250108, 19331, 62550, 62327, 19300, 82473, 61850, 19307, 61861, 38272, 62427, 62249, 62411, 62295, 19334, 19526, 19559, 62000, 61999, 62652, 19064, 58721, 65278, 59433, 83656, 59168, 81898, 59330, 43059, 81890, 58922, 59128, 81897, 58762, 84915, 58131, 59169, 58258, 58949, 59247, 58866, 81853, 58651, 81893, 58263, 84914, 84999, 59199, 59355, 81859, 81891, 58230, 59336, 58242, 58682, 84920, 59430, 59215, 81886, 84908, 81894, 58841, 58720, 84911, 59266, 59257, 59452, 58695, 58343, 59061, 58677, 59356, 58925, 58663, 59282, 58324, 59172, 59203, 59485, 59142, 101557, 68087, 67579, 68218, 67673, 67060, 67995, 67981, 67994, 68209, 68148, 67180, 38890, 67674, 68175, 68164, 67064, 67323, 85631, 59696, 82484, 4187, 38570, 10480, 59191, 13299, 58852, 82480, 38664, 82477, 59367, 59477, 104100, 59680, 58450, 58874, 17433, 83383, 59671, 82504, 58927, 84906, 10479, 58947, 104101, 104093, 59105, 84720, 10437, 13273, 38663, 504114, 59694, 58393, 84974, 58830, 59627, 83657, 59626, 59695, 59486, 59624, 104094, 59684, 82482, 59410, 83621, 82478, 6205, 59686, 59232, 10438, 59482, 59125, 82819, 38569, 58451, 82479, 84921, 83620, 83622, 58395, 59678, 59691, 59322, 82702, 59445, 59062, 61811, 59415, 61705, 61750, 61831, 61566, 61826, 61523, 62326, 61746, 61919, 62343, 62534, 61521, 61998, 85456, 82525, 61511, 62541, 58053, 59397, 59290, 59186, 59106, 59372, 58801, 59178, 59420, 101549, 58899, 59354, 58032, 58012, 58884, 67541, 68190, 67365, 67298, 68127, 68222, 67401, 67357, 67885, 67494, 67545, 68182, 68082, 67417, 67568, 67047, 38945, 67495, 68004, 61937, 62321, 62441, 62351, 61479, 38869, 61752, 61469, 61928, 61827, 62568, 61472, 61774, 62367, 62511, 62194, 61161, 61236, 61176, 61308, 61936, 62599, 62338, 62462, 61971, 62509, 62437, 62258, 62542, 61285, 61797, 62426, 61729, 62396, 61000, 67984, 61003, 62372, 62334, 62277, 62412, 61007, 84960, 61399, 62247, 62246, 62271, 61401, 68206, 62410, 61959, 67996, 38851, 61744, 61930, 59682, 62538, 61806, 67451, 81858, 67989, 67210, 67914, 81883, 67902, 68253, 38891, 67304, 67912, 67909, 68046, 81884, 67540, 67770, 67913, 68084, 67907, 504107, 67814, 67160, 67248, 68225, 67351, 67677, 67291, 67266, 67382, 67169, 68205, 68161, 67928, 68221, 67349, 34153, 67496, 67265, 67930, 67929, 67775, 68119, 38911, 68122, 68172, 67526, 67563, 67927, 67780, 67369, 68158, 67267, 67254, 67316, 67562, 38910, 41387, 67676, 67449, 38864, 67834, 68174, 65218, 37006, 73518, 73857, 73485, 73313, 37008, 37007, 64342, 37009, 64686, 73782, 73833, 73416, 73312, 59660, 37628, 64335, 73873, 64294, 65236, 73868, 65263, 64201, 65210, 73514, 73913, 64152, 64032, 64057, 65254, 64172, 74038, 65167, 64053, 74042, 73955, 64178, 73953, 64107, 82596, 73354, 65245, 81873, 73956, 65224, 73954, 6325, 64088, 64036, 64168, 73827, 64195, 73565, 38669, 59399, 73843, 81874, 74085, 64125, 64073, 64240, 38687, 73994, 73975, 64167, 73887, 74050, 64099, 65234, 73993, 64598, 64673, 58220, 64647, 65183, 73288, 64434, 73401, 73961, 64443, 64355, 64423, 74052, 65289, 82485, 64545, 74065, 73379, 64460, 65196, 73272, 73914, 64430, 38688, 73537, 73991, 64554, 73527, 73940, 64389, 64450, 73413, 73948, 64419, 64511, 64472, 64499, 65173, 65248, 65197, 73848, 64275, 64478, 500005, 64399, 64414, 73866, 73853, 100480, 73451, 64356, 64437, 64404, 59687, 64433, 64410, 64446, 73439, 65247, 64364, 64420, 73881, 6196, 6190, 6207, 6598, 6114, 6871, 6805, 6800, 6412, 6115, 6371, 6335, 6197, 6195, 6188, 6179, 6804, 6791, 84795, 6534, 6670, 6540, 6014, 6186, 84796, 6099, 6747, 6769, 6779, 6341, 59481, 6189, 76821, 6187, X0563, X0562, X0558, X0559, X0535, X0538, X0258, X0564, X0526, X0311, X0316, X0300, 10067, X0301, X0906, X0092, 6487, X0547, X0549, X0519, X0548, X0551, X0313, X0560, X0552, 64514, 44731, 49166, 50170, 44847, 49627, 50093, 43442, 49596, 44856, 44561, 44849, 84917, 74082, 44704, 43025, 49165, 44758, 49296, 44756, 49692, 50144, 44984, 49229, 49718, 49075, 49182, 50092, 49282, 49260, 49185, 49183, 49172, 50049, 49257, 49731, 50041, 49154, 49706, 50106, 49179, 44961, 50133, 44853, 49292, 49714, 83032, 58379, 50123, 49353, 50198, 50005, 49031, 50124, 49580, 49728, 49387, 49499, 50071, 49683, 44762, 50082, 44775, 49673, 84919, 50084, 50000, 50172, 59689, 49607, 49459, 49048, 50001, 50059, 49373, 81876, 50008, 49726, 50040, 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47024, 46416, 46988, 40319, 40070, 47142, 41039, 40076, 83902, 61837, 46478, 40146, 53073, 40293, 47030, 40715, 46992, 47129, 47096, 46966, 40036, 83006, 47010, 40274, 40391, 47143, 47001, 40485, 81895, 40820, 84927, 47088, 40640, 46415, 40214, 40242, 47170, 40199, 46965, 40268, 40186, 40362, 46414, 40227, 40395, 505644, 47003, 46938, 40239, 40251, 46361, 40266, 40700, 40827, 46662, 40255, 47104, 46544, 40363, 40228, 40183, 50391, 46625, 40359, 46402, 100019, 46914, 46912, 40335, 40776, 46429, 40384, 46850, 46937, 40336, 40193, 46953, 46522, 46365, 40351, 40155, 47038, 46523, 46989, 40294, 46939, 40247, 46858, 40747, 46843, 40347, 46554, 46627, 47063, 47059, 40349, 47004, 40817, 46962, 47081, 47268, 44875, 40808, 46623, 40012, 46976, 40322, 40080, 44678, 40047, 40288, 40943, 40049, 100315, 46514, 40337, 40942, 40380, 59622, 40855, 40299, 81928, 47049, 47181, 46253, 81927, 46431, 44725, 46934, 47074, 6991, 46181, 46210, 46285, 46549, 46127, 46128, 46200, 46307, 16765, 81929, 46157, 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The units are distributed to hospitals and medical centers throughout the U.S.
  • Description du dispositif
    BV25 Mobile X-Ray System
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Adresse du fabricant
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA