Events

Rappel de Device Recall Philips Imaging

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 Healthcare 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
    61779
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1689-2012
  • Date de mise en oeuvre de l'événement
    2012-05-02
  • Date de publication de l'événement
    2012-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109064
  • 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, mobile - Product Code IZL
  • Cause
    Unexpected low-level x-ray pulse.
  • Action
    Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Communicate with Philips with regard to this program, please reference Field Change Order 70400049. Further questions please contact your local Philips representative at 1-800-722-9377. On 2/6/15, Philips reported that the recall was extended to an additional 88 units that were unit stock that did receive the correction. Philips issued recall notifcation letter (FCO70400049) on 1/20/2015 to users. Control boards will replaced by a Philips Service Engineer.

Device

Device Recall Philips Imaging
  • Modèle / numéro de série
    Serial numbers: PC1-0504 through PC1 -0588. Extended recall 1/20/2015 (88 units): 484947/SNPC1-0579 375495 423986/SNPC1-0406 423986/SNPC1-0406 423990/SNPC1-0410 465801/SNPC1-0499 465801/SNPC1-0499 365636 365637 365637 365635 392508/SNPC1-0281 479454/SNPC1-0559 352064 352064 323714 455129/SNPC1-0474 423985/SNPC1-0396 423985/SNPC1-0396 411312/SNPC1-0343 411312/SNPC1-0343 328312 328312 345399 345399 345402 345402 345402 380754 380754 424721/SN424721PC1 380965 312998 PC1-0265 314440 314440 386105/SNPC1-0272 425484/SNPC1-0401 425484/SNPC1-0401
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa,Thailand and Ukraine.
  • Description du dispositif
    Philips Practix Convenio Mobile X-ray System || Model: 70455 || The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA