Events

Rappel de PEMView

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 Naviscan PET Systems.

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
    44791
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0041-2008
  • Date de mise en oeuvre de l'événement
    2007-08-01
  • Date de publication de l'événement
    2007-10-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64365
  • 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
    software used with PET Scanner, for nuclear medicine imaging - Product Code KPS
  • Cause
    Naviscan has identified a potential safety issue with all versions of pem view software commonly used for analyzing patient images acquired on the pemfiex product line. 1. the positron emission mammography standardized uptake value (pemsuv) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema.
  • Action
    Telephone notification regarding issues #1 and #2 were carried out on August 1 and 2, 2007 and included instructions for a validated work-around to avoid the software issues. Written notifications with these same validated work-around instructions were sent on August 2, 2007 via certified mail. Customers were notified that Naviscan has identified a potential safety issue with all versions of PEM View Software. Issue #3 was identified after the notification to customers for issues #1 and #2. Telephone notification regarding issues #3 was carried out via telephone and certified mailing beginning August 16, 2007. Customers were informed that Naviscan is preparing software to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure they thoroughly understand the issues and the recommended procedure to prevent these issues from occurring. If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159 or service@navsicanpet.com.

Device

PEMView
  • Modèle / numéro de série
    Serial numbers: C3, P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P14, P002-B-070119-01, P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-01
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
  • Manufacturer
    Naviscan PET Systems

Manufacturer

Naviscan PET Systems
  • Adresse du fabricant
    Naviscan PET Systems, 11180 Roselle St Ste A, San Diego CA 92121-1211
  • Source
    USFDA