Events

Rappel de Device Recall Computed Tomography XRay System MX 8000 IDT 16

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
    56508
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0133-2011
  • Date de mise en oeuvre de l'événement
    2010-07-27
  • Date de publication de l'événement
    2010-10-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94177
  • 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
    Philips healthcare has decided to recall the computed tomography x-ray system mx 8000 idt due to the fact that the software upgrade for the mx 8000 idt 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). if the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap.
  • Action
    Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken. Customers were instructed to locate and correct the error. Field Service Engineers were to visit each site to update the software For further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377

Device

Device Recall Computed Tomography XRay System MX 8000 IDT 16
  • Modèle / numéro de série
    Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia
  • Description du dispositif
    Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. || Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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