Events

Alerte De Sécurité sur Central of Medical Image Processing. Extended Brilliance Workspace (EBW) - ANVISA Registry #: 10216710197

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; Philips Medical Systems Technologies Ltd.; 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
    1200
  • Date
    2012-11-16
  • 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
    • Problem Description Number 1: Use a language other than Chinese • Issue Description Number 2: Do not change to the Agatston protocol before clicking "ok" in the "Side Dialog Box." Problem Description Number 3: Do not add the control point for a spline line • Edit the existing lines, or use a different type of line in Common Tools - Spline Measurement • Problem Description Number 4: In the CT (CTV), first copy the data to the Local and then load to and measure the SUV values ​​Or, load the data into the CT and measure the SUV values ​​in the Slab stage • Problem Description Number 5: On (CTV), copy the data into the Location and then press and measure HOW TO IDENTIFY THE AFFECTED PRODUCTS: The following instructions can be performed to identify the software version of the product: • Click on the button Help "[Help], • Select" About "[About], and the software version is displayed. If you have software versions: 4.0.2, V4.5.2 or V4.5.3, affected Additional information or support for this problem please contact your local Philips representative or your local Philips Healthcare office. If you need any information or support regarding this issue, please contact us by phone: 0800 701 77 89 Monday to Saturday service from 7am to 7pm. Access security letter to clients and lots involved in: http: //portal.anvisa.gov.br/wps/wcm/connect/cf628b004d79453f8f7cefc116238c3b/Aviso+de+Seguran+FCO72800548.pdf? MOD = AJPERES
  • Cause
    1. when translating the results from (cs) to chinese, the percentile is not accurately reported. 2. in the (cs) protocol, the protocol is changed to, however, the name of the protocol remains agatston. 3. spline metering values ​​are not updated by adding control point (cp) and changing row length. 4. in ct (ctv) pet studies being loaded from a remote source other than 1, appears incorrectly in the 2d scene and are not presented with the correct suv values. 5. when loading pet images into the ct (ctv) \ from remote source other than 1, different images appear incorrectly with wrong suv values ​​and qr.
  • Action
    Philips Healthcare is notifying all affected consumers and will install updated software via Request to address these issues. The Philips service department will contact everyone to schedule a time to conduct the appropriate fix and implement the updated software.

Device

Central of Medical Image Processing. Extended Brilliance Workspace (EBW) - ANVISA Registry #: 102...

Manufacturer

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