Important Safety Alerts

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