Events

Safety Alert for iPlan RT Dose version 4.1

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by 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
  • Date
    2012-06-22
  • Event Date Posted
    2012-06-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120622b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: brainlab iplan rt dose version 4.1 medical device manufacturer, brainlab ag issued a medical device safety alert concerning radiation therapy treatment planning system iplan rt dose version 4.1 (v. 4.1.0, 4.1.1 and 4.1.2). according to brainlab, iplan rt dose 4.1 might position the isocenters and rt structures in the dicom ct image files incorrectly if all of the following conditions are met: two or more ct image sets have the same “frame of reference” (same coordinate system). the selected “reference set” and “alignment set” in iplan rt are different ct image sets, but have the same “frame of reference”. for the “reference set” and “alignment set” the used scanner settings differed at least in one of the following parameters: - pixel size - scan range (number of ct images and position) - slice thickness/distance or - matrix size the dicom “full export” - this is not the default “r& v export” - is used to export to a non-brainlab system (e.G. to another radiation therapy treatment planning system). brainlab explained that if all of the conditions above are met, the treatment dose might be delivered to a region different from the planned one. if the deviation would exceed clinically acceptable limits and at the same time be small enough to remain undetected, this could result in serious patient injury and/or ineffective treatment. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

iPlan RT Dose version 4.1
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab iPlan RT Dose version 4.1
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG