{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "76847", "product_res_number": "Z-0347-2009", "event_date_initiated": "2008-12-10", "event_date_posted": "2009-09-24", "recall_status": "Terminated", "event_date_terminated": "2012-08-17", "res_event_number": "50742", "product_code": "IZI", "k_numbers": [ "K022899" ], "product_description": "Integris XPER FD10 F/C", "code_info": "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.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "425-487-7602", "reason_for_recall": "Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.", "root_cause_description": "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.\n\nFirm 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. \nC & R # 1217116-10/20/08-016C", "product_quantity": "306 units", "distribution_pattern": "Worldwide Distribution", "openfda": { "k_number": [ "K810183", "K041027", "K030139", "K842494", "K930635", "K230727", "K972229", "K181537", "K945375", "K231986", "K875374", "K914376", "K944952", "K942503", "K812238", "K100849", "K970525", "K042646", "K955519", "K915232", "K945449", "K904540", "K934496", "K033184", "K982203", "K945400", "K993765", "K853044", "K882358", "K903372", "K842495", "K133719", "K910370", "K063345", "K052039", "K973482", "K875379", "K926258", "K082907", "K922804", 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"892.1600", "device_class": "2" } } ] }