Philips Medical Systems North America Co. Phillips: Integris XPER FD10 F/C

Recall number

Z-0347-2009

Recalling firm

Philips Medical Systems North America Co. Phillips

Product

Integris XPER FD10 F/C

Status

Terminated

Initiated

2008-12-10

Posted

2009-09-24

Terminated

2012-08-17

Reason

Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

Root cause

Radiation Control for Health and Safety Act

Action

An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C

Quantity

306 units

Distribution

Worldwide Distribution

Lot, serial or model codes

FCO 72200111, 72200119, and 72200142 for the 1st phase 72200132 for the 2nd phase Equipment #'s 14147, 38377, 80327, 103147, 104497, 104950, 104953, 105686, 504747, 505254, 505860, 520275, 520793, 522138, 530393, 530667, 531926, 531942, 532226, 532235, 532446, 532611, 532799, 532800, 533278, 533282, 533283, 533289, 533476, 533762, 534634, 534638, 534678, 534731, 534928, 534941, 535212, 535400, 535415, 535416, 535667, 535769, 536138, 536379, 536721, 536966, 537588, 537589, 537630, 537698, 537745, 537855, 537935, 537937, 538084, 538368, 538416, 538432, 538476, 538485, 538486, 538744, 538903, 539107, 539224, 539455, 539480, 539516, 539595, 539641, 540016, 540070, 540234, 540235, 540269, 540301, 540311, 540386, 540488, 540841, 541026, 541029, 541080, 541409, 541510, 541588, 541592, 541597, 541657, 541667, 541822, 542109, 542113, 542117, 543108, 543194, 543198, 543209, 543433, 543610, 543702, 543829, 543873, 543988, 543999, 544048, 544051, 544122, 544145, 544506, 544572, 544600, 544610, 544637, 544990, 544992, 545023, 545037, 545052, 545069, 545296, 545357, 545365, 545395, 545443, 545942, 545966, 546012, 546560, 546561, 546572, 546934, 547159, 547165, 547279, 547321, 547406, 547600, 547660, 547749, 547761, 547762, 547763, 547878, 547908, 547965, 548038, 548067, 548147, 548525, 548603, 548645, 548966, 549013, 549400, 549451, 549738, 549792, 550124, 550172, 550255, 550360, 551379, 551633, 552470, 552585, 552586, 553137, 553234, 553351, 553352, 553430, 553858, 553925, 553986, 554019, 554427, 554431, 554442, 554444, 554499, 554550, 554556, 554631, 554745, 554768, 554791, 554804, 554896, 555206, 555605, 556053, 556311, 556708, 556773, 556783, 557385, 557512, 41416358, 41443581, 41443882, 41444662, 41445229, 41445235, 41445645, 41445816, 41446080, 41446144, 41446290, 41446807, 41455880, 41455894, 41455906, 41455932, 41903960, 42393465, 43067304, 43151051, 43719245, 44048177, and 44604746.  Additional Equipment #s from Phase 2 - 10105, 10483, 13107, 13292, 13914, 13954, 13997, 26218, 38356, 38378, 52463, 62891, 76489, 76867, 76955, 76986, 80322, 84468, 85137, 85190, 85692, 86008, 101949, 102809, 103445, 103554, 103901, 104038, 104201, 104335, 104416, 104910, 104978, 250083, 250146, 250149, 250201, 250674, 505968, 543408, 553964, 553981, 558148, 558198, 41444419, 41444609, 41444680, 41444728, 41445001, 41445032, 41445250, 41445270, 41445303, 41445344, 41445744, 41445766, 41446212, 41446216, 41612034, 41622975, 41793888, 41795224, 42057739, 42067846, 42371287, 42393532, 42508767, 42639096, 42799507, 42799589, 42799745, 42816302, 43179280, 43209360, 43259235, 43270340, 43305020, 43709318, 43721227, 43902667, 43931289, 44193720, 44450326, 44743568, and 45321194.

510(k) numbers

["K022899"]

PMA numbers

not on file

Product code

IZI

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

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