Important Safety Alerts

Medical device manufacturer and distributor, Brainlab AG, has issued a medical device safety alert concerning its RT Elements Radiation Treatment Planning Software [Product Reference: Cranial SRS 1.0.0/1.5.0; Spine SRS 1.0.0/1.5.0; Multiple Brain Mets SRS 1.5.0; RT QA 1.0.0/1.5.0].

The manufacturer has determined that dose distribution calculation by Brainlab RT Elements software may potentially be incorrect when using the Pencil Beam algorithm on the GPU (graphics card) for large tissue models. There has been no report to Brainlab by any user site of undesirable dose distribution delivered to a patient due to this issue at the time of writing.

According to the manufacturer, a risk to patient health cannot be excluded if the issue would re-occur with the affected product versions of Brainlab RT Elements Radiation Treatment Planning Software.

For plans calculated using the affected Pencil Beam algorithm on the GPU, the following data can be reviewed in order to determine whether a patient treatment plan (or QA plan) is affected.

• Determine if the CT scans regularly used in the clinic potentially reach tissue model sizes larger than 512 MB by reviewing the reference graph in the appendix.
• For an accurate evaluation of all calculated plans, the user can determine the exact size of the tissue model stored in the log file, see appendix for detailed explanation on how to find this value.
• If the user find a log file referring to a tissue model bigger than 512 MB refer to the plans created on the date of the log file entry.

The affected users are advised to ensure for all affected applications that the clinically used CT scans do not create tissue models bigger than 512 MB as explained in points 1 and 2 above.

The manufacturer intends the following corrective actions:

• Existing potentially affected customers receive a Field Safety Notice / product notification information (including these customers where the issue was detected).
• The manufacturer will disable the Pencil Beam GPU calculation in the settings of the affected RT Elements Radiation Treatment Planning Software, and thus correct the described issue permanently for all affected customers. The manufacturer will actively contact affected customers tentatively starting April 2019 to schedule the settings change.
• The settings change for all affected customers is tentatively planned to be completed in February 2020.

According to the local supplier, the affected products are distributed in Hong Kong

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 29 March 2019