Events

Rappel de Device Recall EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

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 Ultrasound, 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
    73665
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1380-2016
  • Date de mise en oeuvre de l'événement
    2016-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144689
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    The fasteners securing the control panel assembly to the base of the philips epiq ultrasound system may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.
  • Action
    The firm, Philips, sent an "Urgent-Medical Device Correction" Philips EPIQ Ultrasound System (MDC 79500381/2), letter dated 2016 MAR 23 to consignees on 3/28/16. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of your staff who need to be aware of the contents of this communication. If, at any time, the control panel assembly on your ultrasound system wobbles or feels loose, stop using your system immediately and contact your local Philips representative or Philips Customer Service at 1-800-722-9377. Otherwise, you may continue to use your system. Philips will contact all EPIQ customers to arrange for service to replace the fasteners connecting the control panel assembly to the system with fasteners less likely to loosen with repeated handling. This service will be performed free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377.

Device

Device Recall EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
  • Modèle / numéro de série
    All Serial numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Washington, D.C., and countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mayotte, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿¿union, Romania, Russia , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam.
  • Description du dispositif
    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. || Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Adresse du fabricant
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA