Events

Alerte De Sécurité sur X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, registration 10216710191, models: Brilliance 16-slice (Ar); Brilliance CT 64; Brilliance CT Big Bore; and, registration 10216710209, models: Ingenuity Core; Ingenuity Core 128; Ingenuity Flex. Risk class III.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda.; Philips Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1713
  • Date
    2015-10-07
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the record holder's information, although the problem of image rotation calibration is unlikely to occur, if not detected, the incorrect image can be used to plan radiation therapy treatment, possibly resulting in personal injury / treatment incorrect. Still on company reports, there are two possible categories of risks associated with circle / dot artifacts in the image resulting from an X-ray measurement system firmware error: Incorrect image representation due to artifacts may lead to treatments / surgeries / unnecessary medications, and CT scanning may cause damage from side effects of radiation
  • Cause
    Identified problems in software versions v3.6.1, v3.6.2, v3.6.4, v3.6.5 of the cited products which affect the performance of the equipment. this action involves 03 problems found as stated by the company: //// 1 - image position accuracy - the image rotation calibration program executed by the maintenance engineer can report an approval, but fails to generate the value of the correct angular rotation for ultrafast sweep mode. deviation from inaccurate angular rotation may impact the accuracy of radiation treatment planning. (models involved: brilliance 16-sleice (ar), brilliance ct big bore and ingenuity flex) /// 2 - tracker image artifact due to error in the reconstruction software - the image of the tracker scan of ct angiography (cta) may display an artifact at risk. because of the risk artifact, automatic clinical scanning may be triggered at the wrong time, resulting in unsatisfactory ct diagnostic images that do not capture the bolus peak of the displayed body section. (all models are involved) /// 3 - artifact circle / dot in the image due to x-ray measurement - after a complete shutdown and reclosing of the system, if a head sweep is performed without air calibration and without quick scanning of the iq check after activation, intermittent circle / dot artifacts may occur in the rebuilt images due to a firmware error. (models involved: brilliance 64 ct, ingenuity core and ingenuity core 128).
  • Action
    Philips will correct the errors by installing a software update on the affected systems. The company guides you: 1 - If you identify the image positioning problem described above, Philips suggests that you contact your service representative to perform the image rotation calibration. //// 2 - If you identify the artifact problem in scratches on the tracker image described above, there are three possible outcomes: a. The tracker image may not be affected by the artifact at risk and the scan will be triggered as expected. B. The artifact at risk can cause the tracker to be triggered in advance, generating unsatisfactory results, or; w. The tracker will not fire when the limit is reached. In this case, click "Manually trigger the clinical scan?" [Trigger clinical scan manually?] In the console user interface to start clinical scanning. //// 3 - If you identify an artifact in a circle or point during a head scan, Philips recommends performing a full calibration of the air before the next clinical scan. Action code: FCO72800635. SEE ANNEX LETTER TO THE CUSTOMER.

Device

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, registration 10216710191, models: Brilliance 16-slice ...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA