Events

Safety Alert for COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: 10234230073.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda..

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
    959
  • Date
    2009-03-12
  • 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
    Siemens Ltda reported that it has already begun sending a letter of communication to customers affected by the problem. The updated software version, containing the correction of the problem, is already being elaborated by the company. #### Update on 04/20/2012: According to communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, of 04/19/12), the field action has already been completed - software fix and addendum to the product operation manual.
  • Reason
    The display of an image window acquired with a flat panel optivue (with software version - coherence oncologist - 2.0 or higher) may be offset relative to the reference image.
  • Action
    Siemens Ltda, the company that owns the product registration in Brazil, informed the UTVIG / ANVISA that it has already begun sending letters of clarification to the customers affected by the problem. If they have not yet received the company's letter of clarification, users who own the equipment should contact the company (see the Manufacturer Description field in this alert). Users who have already received the letter of clarification should attach it in the Coherence Oncologist manual until the software update is run by Siemens.

Device

COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: ...

Manufacturer

Siemens Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA