Events

Rappel de Device Recall Big Bore Oncology

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
    74507
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2109-2016
  • Date de mise en oeuvre de l'événement
    2016-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147792
  • 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
    Socket head cap screws (shcs) used in the z-axis adjustment plate were found to be made of stainless steel rather than the specified alloy steel.
  • Action
    Philips Medical Systems (Cleveland), Inc. sent a Customer Information letter dated June 14, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. No action is required of the customer for this issue. Systems that may have been manufactured with these stainless steel fasteners still meet the safety specifications required for the adjustment cradle and may continue to be used clinically. For further information or support customers were instructed to call 1-800-722-9377. For questions regarding this recall call 404-483-2015.

Device

Device Recall Big Bore Oncology
  • Modèle / numéro de série
    Big Bore Oncology System Code 728243; Serial numbers:  75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75030, 75032, 75035, 75036, 75037, 75040, 75042, 75044, 75047, 75048, 75049, 75051, 75053, 75060, 75064, 75100, 75102, 75104, 75105, 750111, 750114
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom
  • Description du dispositif
    Big Bore Oncology tomography X-ray system scanner, model number 728243. || The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the 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