Z-0983-2007

Achieva MRI

Name: Z-0983-2007 Achieva MRI
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-04-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-04-30 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Achieva MRI on 2007-04-30. The reason FDA records is "Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0983-2007
Status: Terminated
Initiated: 2007-04-30
Posted: 2007-06-27
Terminated: 2011-09-21
Recalling firm: Philips North America LLC
Product: Achieva MRI
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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 root cause: 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.
Product codes and lots: 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.

Product code LNH

K031815Class IIIntera-Sensation FamilyPhilips Medical Systems / cleared 2003-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)