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U.S. Department of Health and Human Services

Class 2 Device Recall Intera

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 Class 2 Recall
Intera
see related information
Date Posted June 27, 2007
Recall Status1 Open
Recall Number Z-0982-2007
Recall Event ID 37950
Premarket Notification
510(K) Numbers
K001796  K031815  K041602  K945945 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Intera MRI
Code Information Site numbers: 10009, 10353, 10396, 10432, 13057, 13058, 38134, 38317, 41391, 41441, 62832, 63046, 76919, 82507, 82534, 82582, 82678, 82955, 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, 86235, 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, 101481, 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, 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, 504741, 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, 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, 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, 555563, 556188, 556698, 557713, 557720, 41691292, 41923351, 43668550, 557722/ X1670, 557723/X1730, 557724/X1743, 557759/X1215, 557760/X1216, 557791/X1412, 557793/X1523, 557798/X1577, 557799/X1594, 557804/X1649, 557805/X1662, 557806/X1668, 557807/X1693, 557813/X1753, 557814/X1756, 557843/X1759, 558147/X1281, 558177/X1595, 558200/X1740, 558364/X1562, 558367/X1593, 558369/X1602, 558371/X1648, 558373/X1664, 558374/X1669, 558379/X1739, 558380/X1741, 558381/X1742, and 558382/X1744.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer 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 662 units
Distribution Units were distributed throughout the US to 1,078 hospitals and medical centers.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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