Events

Safety Alert for IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

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

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
    1526
  • Date
    2015-03-11
  • 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 the company's assessment, the severity of the situation is critical if incorrect and unintended positioning occurs for radiation and this is not detected by the user of the product. The possibility of occurrence is remote, as the potential problem occurs only under specific circumstances associated with workflows and specific patient placement scenarios. See Field Safety Notice for additional information. #### UPDATED ON 08/18/2019, the field actions documented by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • Reason
    Potentially incorrect positioning of the patient in linac, when using treatment plans containing several ct scans.
  • Action
    If it is not clinically necessary, do not use multiple scans located within a treatment plan (to avoid, first, possibly incorrect designations of the Reference Set and Alignment Set). If you need to use multiple CT scans, for example, for recurring treatment planning for the same patient, ensure that the last CT scan is defined as both Alignment Set and Reference Set during treatment planning. See Field Security Notice for more information, available at AWARDING PUBLICATION.

Device

IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

Manufacturer

Brainlab Ltda.; Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA