Philips Medical Systems Sales & Service Region No. America: Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C

Recall number

Z-0099-04

Recalling firm

Philips Medical Systems Sales & Service Region No. America

Product

Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C

Status

Terminated

Initiated

2003-10-10

Posted

2004-07-20

Terminated

2005-01-13

Reason

The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.

Root cause

Other

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.

Quantity

536 units

Distribution

The firm distributes to hospitals and medical centers nationwide.

Lot, serial or model codes

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.

510(k) numbers

["K971365"]

PMA numbers

not on file

Product code

EHD

Firm FEI

1000524572

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy