Medical device manufacturer, IBA Dosimetry GmbH, has issued a medical device safety alert concerning its COMPASS Software version 3.1 [Catalogue Number: CS10-100].
Based on a customer complaint the manufacturer identified that COMPASS 3.1 has an error in the reconstruction of the dose distribution for specific plans: Monaco-DMLC and Eclipse IMRT plans with jaw tracking- option enabled. The reconstruction results in the same dose distribution as the dose computation, which has the potential of being erroneous. Based on this information the manufacturer performed a health hazard analysis for COMPASS 3.1and determined that this failure may have an impact on the intended use of COMPASS. The evaluation of the risk for the patient resulted in a region where a risk reduction is necessary. Therefore, the affected customers have to be informed about the malfunction in the software. Additionally the medical device COMPASS 3.1 has to be corrected.
Affected users are advised not to apply patient plan verification for Monaco-DMLC and Eclipse IMRT plans with Jaw Tracking option enabled using the 3D dose reconstruction (measurement-based) calculation method with COMPASS 3.1 until the corrected version is available and installed.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 23 October 2014