Events

Rappel de Integris XPER FD10 F/C

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Co. Phillips.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50114
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2474-2010
  • Date de mise en oeuvre de l'événement
    2008-10-23
  • Date de publication de l'événement
    2010-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74765
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, angiographic - Product Code IZI
  • Cause
    A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
  • Action
    The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.

Device

Integris XPER FD10 F/C
  • Modèle / numéro de série
    Devices are identified with Site Numbers: 41416358, 554019, 43067304, 555206, 550172, 42393465, 554791, 554768, 553234, 41446290, 556783, 41903960, 554550, 544051, 544048, 556311, 41443882, 38377, 554631, 14147, 41445645, 548067, 41444662, 41446080, 41446144, 557512, 553925, 41443581, 41455906, 552586, 41446807, 554427, 556708, 105686, 104497, 104950, 532446, 104953, 530653, 531926, 533397, 504747, 543989, 534478, 535400, 536379, 537065, 520793, 103281, 556053, 41455894, 554804, 557385, 41445235, 41445816, 530667, 530393, 530666, 534731, 532800, 532799, 535416, 531942, 533762, 535667, 535415, 536138, 534634, 536721, 533283, 533282, 533278, 534638, 537698, 536966, 538744, 534678, 538486, 538485, 538476, 537630, 538368, 540016, 539107, 538903, 540841, 540234, 540301, 537745, 540488, 539595, 540269, 103283, 542113, 542117, 539455, 540070, 539641, 540235, 541822, 535769, 547321, 541409, 541592, 541029, 541026, 534941, 547660, 540386, 539480, 543194, 543209, 537855, 538084, 534928, 541597, 540311, 543702, 543198, 543433, 533289, 543108, 544145, 535212, 543873, 538432, 544506, 541588, 544572, 543829, 532226, 543610, 541667, 545037, 545069, 545357, 545365, 545296, 545443, 544990, 544992, 545052, 544610, 545966, 546012, 537588, 541510, 544637, 103147, 546934, 543999, 544122, 520275, 547279, 543988, 546572, 547165, 547908, 548147, 537937, 537935, 537589, 548038, 547878, 549451, 545942, 548525, 545395, 548603, 548645, 547159, 548966, 549013, 539516, 532235, 545023, 547600, 547406, 539224, 549400, 547965, 547749, 549792, 551379, 538416, 550255, 547761, 547763, 547762, 551633, 544600, 541080, 532611, 80327, 554896, 555605, 554499, 546560, 546561,  550360, 553137, 41455880, 550124, 41445229, 41455932, and 556773.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). || Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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