Events

Recall of Achieva

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0983-2007
  • Event Initiated Date
    2007-04-30
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52334
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    magnetic resonance imaging system - Product Code LNH
  • Reason
    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.

Device

Achieva
  • Model / Serial
    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 Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed throughout the US to 1,078 hospitals and medical centers.
  • Product Description
    Achieva MRI
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA