Events

Safety Alert for Central of Medical Image Processing. Extended Brilliance Workspace (EBW) - ANVISA Registry #: 10216710197

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems; Philips Medical Systems Technologies Ltd.; Philips Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1200
  • Date
    2012-11-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    • 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
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA