Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Achieva

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Achieva see related information
Date Initiated by Firm April 30, 2007
Date Posted June 27, 2007
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-0983-2007
Recall Event ID 37950
510(K)Number K031815  
Product Classification magnetic resonance imaging system - Product Code LNH
Product Achieva MRI
Code Information Site numbers: 76359, 76469, 83394, 102114, 103789, 104087, 104163, 104658, 104879, 104924, 105291, 105475, 105624, 500036, 500045, 504634, 505045, 505046, 505048, 505357, 505705, 505879, 506389, 506390, 506798, 506842, 519120, 519124, 519127, 519216, 519552, 519892, 520191, 520315, 520429, 520432, 520667, 520690, 520966, 521097, 521130, 521134, 521150, 521152, 521159, 521465, 521466, 521509, 521513, 521518, 521529, 521536, 521542, 521689, 521718, 521772, 521929, 521934, 522010, 522264, 522422, 528928, 530362, 530395, 530422, 530423, 530426, 530427, 530680, 530771, 530774, 530776, 531765, 531786, 532068, 532410, 532417, 532418, 532470, 532491, 532537, 532643, 532809, 532840, 532851, 532980, 532981, 533063, 533076, 533082, 533086, 533116, 533320, 533393, 533403, 533588, 533743, 533744, 533746, 533747, 533759, 533859, 534069, 534165, 534301, 534344, 534503, 534561, 534587, 534636, 534671, 534693, 534700, 534715, 534721, 534732, 534778, 534838, 534841, 534845, 534925, 534929, 534935, 534944, 534961, 535001, 535189, 535208, 535211, 535222, 535247, 535288, 535289, 535290, 535331, 535353, 535392, 535394, 535404, 535487, 535839, 536597, 536651, 536652, 536675, 536679, 536804, 536943, 537033, 537063, 537133, 537176, 537461, 537508, 537729, 537736, 537795, 537832, 537871, 537880, 538007, 538300, 538452, 538463, 538491, 538525, 538526, 538779, 538789, 538941, 539180, 539183, 539216, 539271, 539327, 539420, 539477, 539550, 539583, 539591, 539703, 539938, 539945, 540015, 540243, 540444, 540469, 540490, 540707, 540999, 541084, 541147, 541200, 541267, 541404, 541491, 541613, 541637, 541797, 541876, 541888, 542595, 542970, 543247, 543278, 543286, 543321, 543696, 543697, 543699, 543888, 543917, 543944, 543992, 544006, 544027, 544563, 544565, 544585, 544640, 544659, 544667, 544704, 544736, 544792, 544911, 545018, 545154, 545219, 545236, 545291, 545294, 545711, 545879, 545914, 545932, 545943, 545999, 546004, 546010, 546015, 546019, 546055, 546096, 546104, 546553, 546570, 546600, 546610, 546637, 546649, 546669, 546730, 546774, 546848, 546864, 546941, 547018, 547023, 547160, 547162, 547228, 547310, 547389, 547585, 547639, 547640, 547698, 547724, 547785, 547788, 547792, 547899, 547941, 547957, 548008, 548010, 548012, 548037, 548359, 548634, 548689, 548729, 548745, 548758, 548760, 548792, 548918, 549009, 549024, 549371, 549373, 549412, 549541, 549666, 549819, 549923, 549936, 550040, 550044, 550195, 550208, 550276, 550279, 550344, 550364, 550366, 550373, 550410, 550731, 550831, 550876, 550926, 550972, 551271, 551401, 551403, 551587, 551656, 551658, 551674, 551872, 551873, 551874, 551875, 551876, 551877, 551878, 551879, 551880, 552189, 552516, 552539, 552588, 552591, 552602, 552604, 552622, 552645, 552805, 552999, 553123, 553583, 553876, 554080, 554466, 554971, 555071, 557429, 41444453, 41445275, 41616878, 42040386, 42057237, 43430017, 43720916, 43756722, 44847380, 47196007, 47598796, and 47801215.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
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.
FDA Determined
Cause 2		 Other
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 361 units
Distribution Units were distributed throughout the US to 1,078 hospitals and medical centers.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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
-
-