Events

Rappel de Device Recall The Pinnacle3 Radiation Therapy Planning 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 Nuclear Medicine, 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
    39420
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1212-2007
  • Date de mise en oeuvre de l'événement
    2007-08-21
  • Date de publication de l'événement
    2007-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55508
  • 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
    Radiation Therapy Planning System - Product Code MUJ
  • Cause
    Incorrect absolute marking coordinates when used with pq-series scanners due to a software malfunction.
  • Action
    All customers will receive an August 21, 2007, Customer Advisory Notification letter notifying them of the issue and the steps required to avoid the issue. Return receipts will be tracked. This is a short-term fix, a long term software fix will be issued shortly by the firm.

Device

Device Recall The Pinnacle3 Radiation Therapy Planning System
  • Modèle / numéro de série
    Pinnacle3 Version 7.6c Software Kit Model #9200-0652A-ENG;Pinnacle3 Version 8.0d Software Kit Model #9200-0700A-ENG;Pinnacle3 Version 8.0d p 1 Software Kit Model #9200-0700B-ENG;Pinnacle3 Version 8.0h Software Kit Model #9200-0700C-ENG
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Country of CANADA
  • Description du dispositif
    The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h)
  • Manufacturer
    Philips Nuclear Medicine, Inc.

Manufacturer

Philips Nuclear Medicine, Inc.
  • Adresse du fabricant
    Philips Nuclear Medicine, Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • Source
    USFDA