Events

Rappel de Device Recall Ingenuity CT 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
    60741
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0693-2012
  • Date de mise en oeuvre de l'événement
    2011-11-11
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106369
  • 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
    Component defect. when the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction.
  • Action
    Philips sent an 'URGENT - Medical Device Correction Ingenuity CT' letter dated November 15, 2011. The letter describes the affected product, problem, hazard involved and actions to be taken by the customer and user. In this case, the customers are advised that extra care should be taken when using the 8-way Gantry Panel switch so as to avoid inadvertently activating an unintended switch resulting in unwanted (couch) movement. The letter notifies the customers that a Philips representative will be visiting each customer site and installing a new control panel through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site ID or follow prompts).

Device

Device Recall Ingenuity CT System
  • Modèle / numéro de série
    The following Serial Numbers of this device are subject to recall: Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. || Product Usage: || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • 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