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
    61102
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1046-2012
  • Date de mise en oeuvre de l'événement
    2011-12-08
  • Date de publication de l'événement
    2012-02-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107302
  • 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
    Design defect. philips learned of this device issue following their receipt of a customer complaint reporting that a 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). a hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or.
  • Action
    The firm, Philips, sent an 'URGENT - Medical Device Correction Ingenuity CT***' letter dated December 08, 2011. The letter describes the affected product, the nature of the problem along witth the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. The customers (operator/users) were instructed not to insert hands in the gap which will be located between the gantry and stationary support column located on either side of the CT System (illustrations are provided). The letter notifies the customers that a Philips representative will be visiting each customer site and installing a hardware upgrade 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 10 or follow prompts).

Device

Device Recall InGenuity CT System
  • Modèle / numéro de série
    The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿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