Events

Rappel de Device Recall PHILIPS EASYDIAGNOST ELEVA

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 Electronics North America Corporation.

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
    78833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0311-2018
  • Date de mise en oeuvre de l'événement
    2017-07-14
  • 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=160639
  • 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, stationary - Product Code KPR
  • Cause
    If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. this may happen when the detector is rotated clockwise from landscape to portrait position.
  • Action
    If the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is . applied. This may happen when the detector is rotated clockwise from landscape to portrait position. The Wireless Portable Detector (WPD) is fixed in the Mobile Detector Holder via a lock mechanisrn. The 4 countersunk screws, that are used to attach the lock mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 clockwise from Iandscape.

Device

Device Recall PHILIPS EASYDIAGNOST ELEVA
  • Modèle / numéro de série
    9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    412 units affected.
  • Description du dispositif
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA