Z-0099-04

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

Name: Z-0099-04 Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2003-10-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-10-10 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C on 2003-10-10. The reason FDA records is "The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0099-04
Status: Terminated
Initiated: 2003-10-10
Posted: 2004-07-20
Terminated: 2005-01-13
Recalling firm: Philips North America LLC
Product: Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.
FDA 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 in commerce: 536 units
Distribution: The firm distributes to hospitals and medical centers nationwide.
Product codes and lots: 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 code EHD

K971365Class IIPhilips Integris H5000Philips Medical Systems North America, Inc. / cleared 1997-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)