Skip to the content

FDA Medical Device Recalls (openFDA)

Philips Medical Systems Sales & Service Region No. America: Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.

Recall number
Z-0097-04
Recalling firm
Philips Medical Systems Sales & Service Region No. America
Product
Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
Status
Terminated
Initiated
2003-10-10
Posted
2004-07-20
Terminated
2006-02-13
Reason
The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
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
570 units
Distribution
The firm distributes to hospitals and medical centers.
Lot, serial or model codes
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
510(k) numbers
["K912470","K923813"]
PMA numbers
not on file
Product code
IZI
Firm FEI
1000524572
Firm city
Bothell
Firm state
WA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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

Search this register