Events

Rappel de Vertical drive brake

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
    50120
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0597-2009
  • Date de mise en oeuvre de l'événement
    2008-09-23
  • Date de publication de l'événement
    2009-01-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74771
  • 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, tomography, computed - Product Code KPS
  • Cause
    The product is being recalled because the patient support may travel downwards without being commanded to move.
  • Action
    A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.

Device

Vertical drive brake
  • Modèle / numéro de série
    Assembly number 4535 664 98912.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Description du dispositif
    Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. || The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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