Events

Rappel de Device Recall Brilliance Big Bore Radiology CT

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
    79134
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0839-2018
  • Date de mise en oeuvre de l'événement
    2018-01-03
  • 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=161424
  • 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
    Software issues including: software errors that may result in extended field of view check message not displayed when field of view is set >600 mm for a paused scan; request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the ct simulation exam card; software errors that may result in tumor loc allowing poi (point of interest) locking when a non-isocenter slice is displayed; software errors that may result in partial set of images or inability to generate ct images.
  • Action
    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated January 2, 2018 to their customers. The letter identified the affected product problem and actions to be taken. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Device Recall Brilliance Big Bore Radiology CT
  • Modèle / numéro de série
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244  Serial #s: 76009 76030 76034 76007 76013 76014 76028 76047 76045 76073 76054 76077 76079 76069 76052 76083 76104 76082 76068 76100 76081 76092 76103 76097 76105 76043 76062 760007 76037 76090 76035 76004 76036 76072 76005 76015 760011 76033 76018 76019 76060 76056 76044 76094 76066 76038 76049 76046 76040 76085 76042 76003 76041 76058 76026 76059 76001 760015 76012 760001 76017 76048 76063 76050 76051 76039 76032 76029 76055 76065 76061 760006 76027 76053 760005 760003 76067 76057 760002 760016 76031 760019 760004 76006 76091 76070 760009 760008 760010 760012 760013 760014 760017 760018 76064 76088 76078 76107 76087 76080 76076 76075 76102 760021 76093 76095 760022 760020 76101 76074 76086 76084 76108 76071 76089 760023 760024 760025 760026
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • 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