Z-0097-04

Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems

Name: Z-0097-04 Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems
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 Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems on 2003-10-10. The reason FDA records is "The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0097-04
Status: Terminated
Initiated: 2003-10-10
Posted: 2004-07-20
Terminated: 2006-02-13
Recalling firm: Philips North America LLC
Product: Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
FDA root cause: 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.
Product codes and lots: 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

Product code IZI

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)