Events

Recall of IPLAN RT DOSE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BRAINLAB AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    86126
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Under certain conditions the isocenter positions and the rt structures exported fron iplan rt dose version 4.1 might be incorrect. as a consequence treatment dose might be delivered to a region different from the planned one.

Device

IPLAN RT DOSE
  • Model / Serial
    Model Catalog: 70228A 70228B 70228C (Lot serial: VERSION 4.1); Model Catalog: 70440 (Lot serial: VERSION 4.1); Model Catalog: 70440A (Lot serial: VERSION 4.1); Model Catalog: 21213D 21213E 21213F (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 70214C 70214D 70214E (Lot serial: VERSION 4.1); Model Catalog: 70213C 70213D 70213E (Lot serial: VERSION 4.1); Model Catalog: 21387 21387A (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 21213D 21213E 21213F (Lot serial: VERSION 4.1); Model Catalog: 21387 21387A (Lot serial: VERSION 4.1); Model Catalog: 70440A (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 70440 (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 70228A 70228B 70228C (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 70214C 70214D 70214E (Lot serial: (v.4.1.0 4.1.1 and 4.1.2)); Model Catalog: 70213C 70213D 70213E (Lot serial: (v.4.1.0 4.1.1 and 4.1.2))
  • Product Description
    iPlan RT Dose v.4.1.0 4.1.1 and 4.1.2
  • Manufacturer
    BRAINLAB AG

Manufacturer

BRAINLAB AG
  • Manufacturer Address
    MUNICH
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    HC