Events

Rappel de Device Recall Allura Xper FD and and Xper FD ORT

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
    79091
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0717-2018
  • Date de mise en oeuvre de l'événement
    2017-12-20
  • 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=161321
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    Extra monitors, so called 7th or 8th monitor, mounted on the monitor ceiling suspension (mcs), might disengage from the mcs and fall down. the two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. if the set screws have come loose gravity can keep the rods in position. however, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. once the monitor has toppled over it is only attached with its wires. if the monitor breaks loose of its wires it will drop on the floor.
  • Action
    Philips sent an Urgent Field Safety Notice letter December 20, 2017 dated to all affected customers. The letter identified the affected product, problem and the actions to be taken. For question contact your local Philips representative.

Device

Device Recall Allura Xper FD and and Xper FD ORT
  • Modèle / numéro de série
    All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001  722002  722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013  722015 722023 722035 722020  722029  722038  722039  722058  722059
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Allura Xper FD and and Xper FD ORT - Philips X-ray Systems || Product Usage: || The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
  • 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