Events

Safety Alert for ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

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
    958
  • 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
    According to a communication letter sent to UTVIG / ANVISA by Siemens Ltda, the company will send a communication letter to its customers. The company also reported that equipment under risk in the country has not yet been installed, that is, they are not yet in operation. #### Update on 04/20/2012: According to communication sent on 04/17/2012, 2012 by the company for UTVIG / ANVISA (file no. 0324770128 of 04/19/12), the company has already closed the field action. The three equipments affected by the problem in Brazil were corrected by the company through a software update.
  • Reason
    The display of the equipment may be misaligned by about 4mm when compared to the reference image. with this, a single exposure image can be overwritten by a dual exposure image.
  • Action
    The company that owns the product registration, Siemens Ltda, has not yet begun to communicate with users affected by this alert. According to the company, to avoid the possibility of overwritten images from a single exposure by a dual exposure image, users should acquire / load images of the same type of exposure during a session. If this recommendation is difficult to implement at the health facility, users are advised to select SAVE (save) to each image immediately after a modification. The ANVISA Technovigilance Unit (UTVIG / ANVISA) is monitoring this case.

Device

ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

Manufacturer

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