Events

Rappel de Device Recall Philips IntellVue Info Center

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
    64507
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1783-2014
  • Date de mise en oeuvre de l'événement
    2013-03-05
  • Date de publication de l'événement
    2014-06-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116367
  • 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
    Monitor, Physiological, Patient (with arrhythmia detection or alarm) - Product Code MHX
  • Cause
    If a customer creates customized trend scales in the trend review tile and the ix or primary server reboots for any reason, the ix(s) will enter a reboot loop. if one ix reboots, the issue will impact only those patients monitored on that device. if the primary server reboots, all patients across all ix devices will be impacted.
  • Action
    On 3/5/13, Philips sent each known affected customer an Urgent Medical Device Correction notification/Field Safety Notice to inform them that Philips has received a customer report that the PIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. In order to prevent this from occurring, customers were advised to not modify/customize the default trend scales for reviewing stored patient data in the retrospective review applications. Recall letter also states that a Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIX iX software resolving this issue on affected units. Philips will conduct these updates for all affected devices at no charge.

Device

Device Recall Philips IntellVue Info Center
  • Modèle / numéro de série
    All iX versions with A.01 software
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Description du dispositif
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
  • 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