Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27485
  • Event Risk Class
    Class 2
  • Event Number
    Z-0099-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29939
  • Notes / Alerts
    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.
  • Extra notes in the data
    Unit, X-Ray, Extraoral With Timer - Product Code EHD
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes to hospitals and medical centers nationwide.
  • Product Description
    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
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA