Events

Rappel de Device Recall 90JAK System, Computed Tomography Xray Scanning 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 Medical Systems (Cleveland) 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
    30359
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0957-05
  • Date de mise en oeuvre de l'événement
    2004-03-23
  • Date de publication de l'événement
    2005-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35728
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Cause
    Software anomaly in the dicom modality worklist. when restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
  • Action
    The firm mailed a ''Product Safety Notification'', dated 3/23/2004, to all users who had DICOM Modality Worklist enabled with a software key. The customers were notified of the problem and were provided instructions as to how to prevent the anomaly from occurring. The notification also informed the users that updated software which corrects the anomaly will be available in the near future and will be installed by the firm''s Field Service Engineers.

Device

Device Recall 90JAK System, Computed Tomography Xray Scanning System
  • Modèle / numéro de série
    All devices manufactured between January 1996 and June, 2004 were subject to recall.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Austria, Italy, Netherlands, Spain, United Kingdom, and Sweden. The units were installed in medical facilities located in the following states within the U.S.: KS, PA, FL, MN, IA, CA, GA, LA, MS, OH, NE, MO, IN, TN, TX, MI, NM, MA, AL and NH;
  • Description du dispositif
    AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA