Events

Rappel de Device Recall Philips Healthcare Ingenuity Core

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
    78852
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0390-2018
  • Date de mise en oeuvre de l'événement
    2017-11-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160869
  • 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 has identified that certain fasteners cannot be confirmed to have been torqued according to specification. if the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
  • Action
    An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.

Device

Device Recall Philips Healthcare Ingenuity Core
  • Modèle / numéro de série
    Code 728321, SN # 310094
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
  • Description du dispositif
    Ingenuity Core, (Code 728321) || Intended to produce images of the head and 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 Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA