Events

Rappel de Device Recall Philips Healthcare PCR Eleva Radiological Image Processing 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 Healthcare 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
    59473
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3205-2011
  • Date de mise en oeuvre de l'événement
    2011-07-27
  • Date de publication de l'événement
    2011-09-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102849
  • 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
    Computed Radiography Image Processing System - Product Code LLZ
  • Cause
    The mirror icon on the bottom of each image could be interpreted as a right marker for side indication if the image is mirrored again within a pacs system. this could potentially lead to a misdiagnosis.
  • Action
    Philips Healthcare Inc. sent out "Urgent --Medical Device Correction" notices dated June 10, 2011 to all affected customers. The letter described the product and problem. Customers were informed the "burned-in Mirror-Icon" may be misinterpreted as a Right marker. Customers are advised to preferably use lead markers during each X-ray acquisition or alternatively electronic annotations on each image for side indication. The presentation of these markers within each image will clearly show the difference between the intended Left/Right indication and the little mirror ICON. Philips will install improved software that prevents the misinterpretation of the symbol and will schedule the installation of the updated software. For questions on this recall call Phillips Healthcare Inc. at 978-687-1501.

Device

Device Recall Philips Healthcare PCR Eleva Radiological Image Processing System
  • Modèle / numéro de série
    Software version 1.2 Models: 732040, 732042, 732044, 732048, 732050, 732052, 732080, 732082
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.
  • Description du dispositif
    PCR Eleva Radiological Image Processing System with software R.1.2 || Philips Healthcare, Inc. || A computed radiography image processing system.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA