Events

Rappel de IMPAX 6.5

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 AGFA Corp..

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
    58565
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2246-2011
  • Date de mise en oeuvre de l'événement
    2011-04-05
  • Date de publication de l'événement
    2011-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99598
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Software issue that occurs after dictation of a study.
  • Action
    Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization.

Device

IMPAX 6.5
  • Modèle / numéro de série
    35A2Y000, 35AWO000, 5N2N4004, 5NP9X001, 5NSMY000, 5OHXO000, 5QFWU000, E5KN2002, ETQ55000, EU5P6000, EYMFF000, F8AM4771, L18HH000, L2CEW000, L41KH000, L5N26000, L5N4B000, L5N5D000, L5P6O000, L5PD1000, L6S8E000, L8L5U000, L8VHQ000, L9HGC000, LEFG2504, LVTB7007
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- including states of WI, and SC.
  • Description du dispositif
    IMPAX 6.5 Client Software. || IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Adresse du fabricant
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA