Events

Rappel de Device Recall INTEGRIS H5000

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 Electronics North America Corporation.

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
    72599
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0722-2016
  • Date de mise en oeuvre de l'événement
    2015-11-03
  • Date de publication de l'événement
    2016-01-30
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142410
  • 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
    The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
  • Action
    The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

Device

Device Recall INTEGRIS H5000
  • 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 Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Description du dispositif
    INTEGRIS H5000; Model Number: 72246 || The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA