Events

Rappel de Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50

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 Informatics, 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
    68262
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1646-2014
  • Date de mise en oeuvre de l'événement
    2014-05-05
  • Date de publication de l'événement
    2014-05-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127235
  • 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
    Medical device data system - Product Code OUG
  • Cause
    When using xiris rio version (8.1.50.0) in conjuncture with isite pacs a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed.
  • Action
    Philips Healthcare sent an Urgent Field Safety Notice dated May 5, 2014. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the synchronization problem and request that a copy of this notification be kept with the equipment instructions for use. The document goes on to outline the affected product, the problems and conditions when it can occur. A photo of the label for easy identity the actions to be taken are provided. Philips is informing users of the issue via the notification and will deploy a software correction to all customers when available. Questions may be directed to Philips reps or Care at 1-866-946-4701 or OneEMSProd@philips.com

Device

Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50
  • Modèle / numéro de série
    Model XIRIS 8.1 version XIRIS 8.1.50.0
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
  • Description du dispositif
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 || XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • Adresse du fabricant
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA