FDA Home Page | CDRH Home Page | Search | A-Z Index

510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards

New Search Back To Search Results   Medical Device Recalls Class 2 Recall Intera Date Recall Initiated April 30, 2007 Date Posted June 27, 2007 Recall Number Z-0982-2007 Product Intera MRI Code Information Site numbers: 10009, 10353, 10432, 13057, 13058, 38134, 38317, 41391, 41441, 62832, 63046, 76919, 82507, 82534, 82678, 83051, 83080, 83301, 83303, 83306, 83325, 83395, 83396, 83616, 83631, 83802, 83804, 83916, 83940, 83941, 83946, 83995, 84418, 84433, 84477, 84478, 84484, 84700, 84820, 84860, 84861, 84887, 84899, 85023, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85436, 85442, 85443, 85500, 85684, 85685, 85686, 85688, 86012, 86019, 86020, 86056, 86080, 86082, 86083, 86085, 86121, 86147, 86148, 86184, 86236, 86248, 86250, 86280, 86281, 86287, 86292, 86293, 86313, 86316, 86317, 86334, 86335, 86368, 86379, 86380, 86381, 86404, 86406, 86407, 86408, 86409, 86410, 86413, 86555, 86556, 86557, 86558, 86559, 86560, 86570, 86595, 86596, 86597, 86925, 86968, 87010, 87011, 87018, 87019, 87033, 87034, 87036, 87038, 87053, 87062, 87067, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87311, 87355, 87526, 87527, 87604, 87605, 87607, 100214, 100323, 100449, 100459, 100460, 100461, 100462, 100469, 100478, 100629, 100679, 100745, 100785, 100786, 100826, 100832, 100886, 100916, 101056, 101070, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101412, 101416, 101420, 101423, 101425, 101429, 101431, 101432, 101477, 101551, 101560, 101561, 101572, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101953, 101976, 102003, 102004, 102018, 102095, 102101, 102110, 102137, 102157, 102194, 102353, 102492, 102497, 102524, 102547, 102548, 102561, 102569, 102571, 102614, 102617, 102671, 102698, 102699, 102709, 102718, 102724, 102786, 102827, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103064, 103065, 103068, 103098, 103099, 103101, 103126, 103135, 103136, 103142, 103143, 103149, 103151, 103166, 103171, 103207, 103215, 103243, 103247, 103249, 103258, 103286, 103291, 103324, 103333, 103347, 103351, 103373, 103416, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103620, 103631, 103647, 103665, 103688, 103697, 103703, 103704, 103770, 103779, 103782, 103808, 103811, 103817, 103818, 103847, 103904, 103907, 103909, 103911, 103946, 104019, 104022, 104027, 104032, 104054, 104069, 104070, 104079, 104082, 104095, 104102, 104124, 104134, 104138, 104144, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104531, 104532, 104635, 104639, 104765, 104800, 104808, 104871, 104880, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104928, 104942, 105148, 105252, 105271, 105290, 105303, 105311, 105313, 105314, 105315, 105317, 105348, 105358, 105368, 105373, 105424, 105471, 105486, 105487, 105488, 105509, 105657, 105664, 105679, 105687, 105695, 105720, 105741, 105925, 105926, 105929, 105938, 225313, 250033, 250050, 250122, 250156, 250180, 250229, 250293, 250498, 250890, 500007, 500009, 500010, 500034, 500051, 504243, 504249, 504298, 504335, 504342, 504346, 504349, 504350, 504351, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504653, 504662, 504670, 504738, 504793, 504866, 504899, 504927, 504952, 504954, 504974, 504979, 505007, 505021, 505049, 505050, 505275, 505337, 505399, 505400, 505490, 505514, 505568, 505678, 505682, 505688, 505689, 505777, 505785, 505815, 505914, 505940, 505941, 505943, 506034, 506044, 506120, 506183, 506188, 506190, 506203, 506219, 506296, 506324, 506385, 506570, 506670, 506691, 506777, 506784, 519129, 519133, 519147, 519525, 519545, 519569, 519765, 519890, 520002, 520113, 520176,520190, 520354, 520355, 520579, 520662, 520679, 520700, 520708, 520709, 520754, 520765, 521228, 521415, 521429, 521432, 521524, 521678, 521751, 521908, 521911, 521927, 521939, 522297, 522419, 522421, 522441, 530363, 530364, 530366, 530651, 531652, 531712, 531766, 531767, 531925, 531934, 532282, 532463, 532705, 532709, 532710, 532711, 533489, 533682, 533953, 534643, 534676, 534684, 534686, 534695, 534765, 534777, 535327, 535328, 535329, 535330, 535486, 535505, 536126, 536262, 536318, 536482, 536589, 536885, 537391, 537690, 537980, 538077, 538253, 538429, 538800, 538841, 539236, 539276, 539280, 539281, 539531, 539585, 539597, 539644, 539882, 540285, 540412, 540454, 540793, 540794, 540945, 541125, 541441, 541442, 541575, 541740, 541819, 541827, 541973, 542116, 542270, 542275, 542580, 543118, 543119, 543280, 543293, 543724, 543824, 543892, 543966, 543976, 544085, 544112, 544116, 545008, 545084, 545255, 545541, 545573, 545832, 545842, 545940, 545952, 545965, 545980, 546177, 546970, 547066, 547075, 547235, 547261, 547587, 547903, 547934, 547953, 547979, 547985, 548050, 548065, 548320, 549239, 549243, 549429, 549592, 549858, 550035, 550057, 550060, 550085, 550256, 550391, 550422, 550909, 551037, 551689, 552498, 552508, X1215, X1216, X1281, X1412, X1523, X1562, X1593, X1594, X1595, X1602, X1648, X1649, X1662, X1664, X1668, X1669, X1670, X1693, X1730, X1739, X1740, X1741, X1742, X1743, X1744, X1753, X1756, X1759 Recalling Firm/ Manufacturer Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell , Washington 98021-8431 For Addition Information Contact Sarah Baxter 425-487-7665 Reason For Recall Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site. Action On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated. Quantity in Commerce 640 units Distribution Units were distributed throughout the US to 1,078 hospitals and medical centers.

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH