Medical device manufacturer, Brainlab AG, has issued a Field Safety Notice concerning all Brainlab BrainSCAN and iPlan RT treatment planning software versions.
According to Brainlab, the accuracy of the Brainlab radiotherapy treatment planning software was not within clinically desirable limits for very small Multi-Leaf-Collimator field sizes. If not recognized by the user with the recommended treatment plan quality assurance, the irradiation of such a treatment plan might lead to serious injury of the patient and/or ineffective treatment.
Brainlab is notifying affected customers with a field safety notice and will provide an updated Instructions for Use to them. The tentative availability of the update will be in June 2012.
According to the local supplier, the affected devices were distributed to Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.