Events

Recall of Device Recall Integris Allura

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
    37012
  • Event Risk Class
    Class 2
  • Event Number
    Z-0366-2007
  • Event Initiated Date
    2006-12-14
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49758
  • 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
    angiographic x-ray systems - Product Code IZI
  • Reason
    Movement of the ad5 table or lateral c-arm (larc). the table and/or larc will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
  • Action
    On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.

Device

Device Recall Integris Allura
  • Model / Serial
    site numbers 534928, 545964, 532207, 545365, 538387, 543397, 543398, 543399, 546572, 544581, 544728, 548147, 547005, 539456, 543953, 547234, 547364, 545838, 545839, 545840, 544395, 547952, 530393, 545799, 540790, 547431, 544122, 541659, 546060, 543433, 545604, 543198, 545921, 545640, 545966, 541590, 540456, 546201, 541572, 544130, 544635, 534665, 542963, 535303, 541783, 544631, 540930, 544610, 544506, 546456, 544989, 544990, 544992, 543984, 543759, 546906, 543873, 543087, 543108, 547279, 546908, 544750, 545518, 545052, 545539, 543799, 543411, 547660, 543229, 544371, 548288, 546668, 545714, 537604, 541046, 544513, 545583, 540808, 545280, 548039, 544489, 544120, 540275, 540284, 540952, 544637, 547855, 545941, 545753, 541597, 545025, 536030, 544543, 546693, 548140, 546025, 545752, 547976, 543971, 543972, 539634, 545749, 546119, 545750, 547642, 544433, 545069, 545073, 547777, 547321, 547628, 545733, 547392, 545293, 545296, 547908, 541880, 543386, 546013, 548061, 545282, 533398, 541588, 541589, 540374, 545357, 542486, 545443, 546012, 545090, 545037, 538432, 532226, 540407, 103281, 104950, 531926, 104953, 530653, 520630
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to hospitals and medical centers nationwide.
  • Product Description
    Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9' Image Intensifier
  • 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