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U.S. Department of Health and Human Services

Class 2 Device Recall Monitor Ceiling Suspension

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  Class 2 Device Recall Monitor Ceiling Suspension see related information
Date Initiated by Firm October 10, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 13, 2006
Recall Number Z-0097-04
Recall Event ID 27477
510(K)Number K923813  K912470  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
Code Information Part Numbers: 9807 605 71009, 9896 000 36771, 9896 000 36772. The firm uses site numbers as their serial numbers. Site Numbers: 76808, 6838, 35445, 38929, 62374, 41372, 74032, 17656, 44744, 50026, 44772, 38922, X0346, X0934, 41111, 38993, 6981, 6842, 59515, 6852, 6853, 44760, 67565, 62392, 74007, 44299, 44337, 41000, 25923, 35484, 37878, 6498, 44328, 41378, 45039, 41426, 62003, 37932, 13879, 25750, 41031, 76213, 62666, 62667, 76329, 44898, 41156, 37907, 38944, 45042, X0344, 38912, 40941, 46931, 62885, 13721, X0855, 6931, 46926, X1078, 47033, 44593, 100014, X1077, 76804, 44865, 13918, X0917, 76449, 74026, 6937, 6648, 25945, 35403, 25987, 35471, 73522, 47160, X1207, 50317, 47128, 6539, 76085, 17436, 59524, 47166, 17605, 50251, 76388, 47060, 26071, 73908, 62502, 62504, 62444, 67609, 67597, 67610, 37872, 37874, 62304, 6820, 44825, 41128, 62377, 73428, 13317, 61871, 41109, 26108, 26118, 41360, 6552, 26063, 59610, 59611, 37879, 37937, 37992, 73793, 25773, 25908, 26038, 26039, X0483, 35593, 67580, 37880, 45026, 62376, 6738, 35500, X0672, X0078, 16712, 16713, X0042, 16690, 17382, 17492, 76465, 46879, 35473, 62385, 59423, 13731, 50152, X0404, 35153, 67221, 67225, 68028, 68044, 68159, 67428, 59295, 59377, 13310, 62289, 59279, 59302, 59380, 47138, 50091, 6601, 6784, 6785, 37959, 6739, 67811, 37924, 34685, 35356, 59249, 59255, 17457, 17458, 67277, 68100, 45051, 46423, 34808, 40161, 47117, 47171, 13617, X0036, X0939, 34659, 41163, 41164, 25699, 52396, 52131, 59296, 61970, 31023, 35303, 25809, 35310, 40271, 46468, 43914, 41026, 62505, 25725, 62390, 73865, 74046, 59551, 17474, 62940, 37910, 38986, 67334, 67992, 62636, 62638, 38554, 59360, 61892, 15207, 62317, 13502, X0041, 6591, 25952, 41017, 59188, 67279, X0402, 76148, 62315, 62335, 6654, 25999, 25965, 25973, 15215, 74080, X0063, 25935, 25948, 25706, 25666, 25895, 50180, 62483, 62314, 38916, 35217, 13492, 25886, 59237, 59364, 46928, 13482, 73423, 73912, 15186, 50025, 67129, 76076, X0501, X1275, X1345, 4295, 6090, 6236, 6410, 46068, 58460, 59111, X0978, X1164, 104853, 67628, 73896, 62649, 62967, 46961, X0398, X0400, X0406, X0407, X0410, X0503, X0510, X0621, X0669, X0670, X0754, X0838, X0846, 62340, 73878, 49677, X0789, 67587, 61976, 34728, X0044, 25909, 59276, 46633, X1185, 59396, 44671, 73498, 41242, 44689, 35364, 104480, 25998, 62999, 47089, 26062, 16757, 44697, 17264, 13633, 13639, 37837, 44609, 59391, 25964, 37877, 37988, 13383, 13599, 44791, 17453, 25835, 25836, 25838, 13562, 6733, 76342, 6609, 6610, X0093, 37970, 26061, 59231, 25950, 73988, 44323, 40007, 73880, 35229, 62339, 38080, 25917, 6821, 44623, 13519, 10414, 25849, 6656, 6869, 59527, 74012, 76084, 44826, 44288, 44740, 62521, 13503, 25842, 34699, 44698, 52339, 59368, 62435, 62436, 67354, 47169, 47140, 62268, 26109, 6803, 40127, 44848, 50130, 59139, 59218, 59346, 13605, 6671, 59301, 73908, 68098, 17528, 35489, 62346, 74053, 50103, 61941, 67336
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		 The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
FDA Determined
Cause 2		 Other
Action The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.
Quantity in Commerce 570 units
Distribution The firm distributes to hospitals and medical centers.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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