Events

Rappel de Device Recall BrightView, BrightView X, BrightView XCT

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 (Cleveland) Inc.

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
    69783
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0450-2015
  • Date de mise en oeuvre de l'événement
    2014-11-04
  • Date de publication de l'événement
    2014-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131535
  • 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, tomography, computed, emission - Product Code KPS
  • Cause
    Software issues.
  • Action
    Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these issues, please contact your local Philips representative: For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). Philips apologizes for any inconveniences caused by this problem.

Device

Device Recall BrightView, BrightView X, BrightView XCT
  • Modèle / numéro de série
    BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109.  BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493, 4000497, 4000500, 4000517, 4000595, 4000599, 4000605, 4000609, 4000616, 4000617, 4000622, 4000648, 4000653, and 4000675.  BrightView XCT: 6000018, 6000024, 6000025, 6000029, 6000059, 6000072, 6000074, 6000096, 6000097, 6000106, 6000155, 6000170, 6000179, 6000217, 6000255, 6000259, 6000272, 6000328, 6000342, 6000357, 6000388, 6000405, 6000412, 6340011, and 11000082.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
  • Description du dispositif
    BrightView product code: 882478 || BrightView X product code: 882480 || BrightView XCT product code: 882482 and 882454
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA