Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- October 10, 2003
- Posted
- July 20, 2004
- Terminated
- January 13, 2005
- Recall Number
- Z-0099-04
- Quantity
- 536 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.
Distribution
The firm distributes to hospitals and medical centers nationwide.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.