Events

Rappel de Clea Stand Ceiling used with the Integris XRay System H5000, Allura 12/15, Allura 9C

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
    27485
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0099-04
  • Date de mise en oeuvre de l'événement
    2003-10-10
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29939
  • 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
    Unit, X-Ray, Extraoral With Timer - Product Code EHD
  • Cause
    The cable carrier and cables may fall after repeat collisions with or lamps, radiation shields or other supported accessories.
  • Action
    The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier.

Device

Clea Stand Ceiling used with the Integris XRay System H5000, Allura 12/15, Allura 9C
  • Modèle / numéro de série
    Part Numbers 986 000 75921 + 9896 000 75922, 9896 001 32411 + 9896 001 32412, 9896 001 31981 + 9896 001 31982. The firm uses site numbers instead of serial numbers. Site numbers: 102674, 105731, 105514, 102009, 105491, 13093, 86561, 10105, 103382, 100434, 100328, 103287, 85633, 85635, 86456, 38728, 85090, 38592, X1732, X1733, 103290, 103150, 104565, 82612, 103957, 76499, 10439, 10440, 13117, 86289, 104335, 103494, 101135, 101136, 101040, X1596, 102983, 82528, 41461, 100504, 103554, 85126, 85131, 86594, 87324, 13118, 83016, 103860, 101948, 82692, 103282, 86135, 101589, 103379, 100708, 103002, 103214, 104412, 104975, X1695, 87339, 101971, 10464, 100685, 102723, 103557, 86196, 10482, 102348, 101965, 86398, 38373, 76511, 87012, 102564, 102179, 104865, 102664, 103456, 104416, 104978, 13289, 103026, 38925, 102521, 104974, 82526, 101938, 86367, X1408, X1540, 86585, 86599, 100689, 83313, 82576, 38795, 41480, 104425, 104426, X1687, 105511, 105686, 85498, 38358, 102855, 102856, 85014, 100503, 86253, 100701, 86144, 10478, 82950, 85676, 101239, 102493, 86571, 102793, 86914, 102863, 103712, 104580, 104581, 38356, 104169, 104170, 101139, X1738, X1736, 86935, 76830, 104511, 86066, 100262, 101606, 101607, 103711, 85488, 100657, 86434, 83015, 83996, 13109, 86981, 76962, 100811, 76931, 76932, 76933, X1690, 100683, X1327, 103221, 103991, 86577, 50222, 50223, 83807, 13107, 13997, 100612, 76545, 102808, 102810, 101612, 10391, 101873, 103891, 76986, 86136, 76559, 41288, 52472, 86061, 102809, 104427, 101582, 101583, 103630, 100658, 102193, 102502, 86575, 103721, 86319, 103029, 101036, 85195, 102868, 84443, 82823, 10104, 85093, 104402, 102872, 101465, 104056, 100948, 87603, 100949, 100950, 82522, 102248, 104062, 85106, 100839, 86321, 103248, 84444, 84466, 84468, 100607, 101864, 76528, 87081, 83994, 62940, 45077, 102161, 104529, 103714, 100945, 103246, 104424, 50399, 100643, 10454, 85416, 100913, 76556, 76557, 101566, 102612, 86502, 105299, 104076, 102945, 102953, 13883, 105309, 105254, 100840, 85129, 26117, 86145, 76917, 84789, 85028, 86063, X1168, 41139, 103746, 86290, 103327, 76514, 100316, 105098, 105294, 100611, 102675, 86008, 103335, 86341, 38146, 87532, 103144, 102791, 84447, 100865, 82575, 26161, 82822, 103133, 41145, 101928, 102156, 103650, 86411, 86989, 103371, 85503, 85639, 85010, 85011, 103901, 105389, 103336, 76987, 102096, 103004, 87300, 86576, 102589, 85107, 86420, 86495, 103709, 102826, 83924, 103776, 104976, 14147, 76527, X1584, 103879, 82517, 82523, 86295, 86537, 87316, 82699, 83024, 102890, 84489, 41460, X1724, X1699, 104038, 103777, 102635, 100587, 86320, 100810, 101617, 101618, 86982, 102811, X1262, X1282, X1284, X1389, X1697, 102944, 38261, 85499, 82537, 86433, 102776, 103875, 76577, 100470, 87197, 103169, 104797, 87528, 86435, 103926, 10441, 100645, 82824, X1688, 85445, 86422, 86088, 103231, 103240, 41104, 100783, 83861, 83862, 50371, 50373, 102572, 104539, X1146, 102098, 87004, 86994, 103587, 52463, 104077, 103034, 59703, 87337, 14168, 100585, 102418, 76525, 100869, 102094, 102487, 103819, X1528, 104145, 101576, 82696, 84445, 86189, 101077, 102180, 100475, 100477, 84721, 38425, 102817, 102871, 85128, 13114, 100485, 100486, 100487, 104418, 38702, X1476, 86421, 100866, 103372, 85013, 100630, 100631, 103793, 105733, 14145, 50433, 101078, 102842, 100959, 102631, 102160, 102162, 83042, 100521, 38201, 13296, 100656, 86972, 13292, 102166, X1717, X1718, 103266, 85169, 103032, X1716, 10442, 85041, 86975, 91650, 100696, 102001, 103900, 76918, 87319, 76505, 50438, 82520, 82719, 104885, 84713, 103828, 38276, 85135, 86183, 82825, 104337, 103182, 103183, 86360, 104410, 103512, 50339, 86536, 86542, 76867, 102823, 76883, 73884, 76885, 76886, 104933, 102083, 102995, 104798, X1685, X1686, 102037, 87366, 87069, 104541, 102632, 13290, 85094, 84482, 86296, 104187, 103929, 104513, 103584, 103612, 50374, 101208, 86506, 76510, 85196, 86065, 102558, 102563, 104430, 87013, 103070, 86581, 101966, 103237, 80330, 102934, 100788, 103193, 85133, 101485, 100613, 76880, 76882, 86933, 86953, 82815, 86578, 103594, 100319, 83838, 104060, 86437, 87364, 103823, 100714, 103987, 86172, 86272, 87179, 101973, 83326, 83375, 101309, 50335, 100432, 104422.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm distributes to hospitals and medical centers nationwide.
  • Description du dispositif
    Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
  • 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 Highway, Bothell WA 98041
  • Source
    USFDA