Events

Safety Alert for Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surgical / Clinical Planning Software ///. ANVISA registration number: 80042070008 ///. Risk class: III - High Risk

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
    2017
  • Date
    2016-10-07
  • 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
    1) Immediately check the Leaf Shift Static value on all of your machine profiles on the iPlan RT Dose for MLC Elekta Agility: Ensure that this value is set to "0 mm". If another value is set, change this specific value to 0 (zero) to permanently resolve the potential problem described. 2) Return the Customer Response Form attached to the Product Notification to Brainlab.
  • Reason
    Potential effect of incorrect calculation of dose distribution when using treatment planning iplan rt dose with multiline collimator (mlc) elekta agility under specific circumstances. if the effect occurs for these specific treatment plans and is not detected by the user with the corresponding treatment-specific quality control, this may result in an unrecognized accumulated dose leak and not considered in small tissue regions, which may exceed the clinically acceptable limits and essentially causing undesirable long-lasting effects to the patient. no occurrences have been reported to brainlab by users regarding unwanted dose distributions administered to patients due to this problem.
  • Action
    Field Action Code CAPA-20160909-001728 triggered under the responsibility of the company Brainlab Ltda. Company is making correction in field of software update.

Device

Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surg...

Manufacturer

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