Events

Rappel de Device Recall Precedence SPECT/CT System Upper Patient Pallet

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 Phillips Nuclear Medicine.

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
    51274
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0897-2011
  • Date de mise en oeuvre de l'événement
    2009-01-26
  • Date de publication de l'événement
    2011-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79567
  • 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
    Table, powered - Product Code INQ
  • Cause
    A problem has been identified with some upper patient pallets on precedence spect/ct system, which may reduce its load bearing capacity and may result in its cracking. if this were to happens, could pose a risk to patient.
  • Action
    The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.

Device

Device Recall Precedence SPECT/CT System Upper Patient Pallet
  • Modèle / numéro de série
    Serial Numbers: 3000037, 3000048
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    International distribution only: Mexico and Saudi Arabia.
  • Description du dispositif
    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, || Model Number: 4535 602 50851, Catalog Number: 882350, || Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH || Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
  • Manufacturer
    Phillips Nuclear Medicine

Manufacturer

Phillips Nuclear Medicine
  • Adresse du fabricant
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA