Recall Z-1205-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
Brainlab AG
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereot
| Date | Mar 11, 2019 |
| Status | Terminated |
| Reason | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting. |
| Root cause | Device Design |
| Action | On March 11, 2019, Brainlab sent FIELD SAFETY NOTICE/PRODUCT NOTIFICATION emails to their consignees advising them of the problem. Brainlab 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. |
| Quantity | US - 164 units; Outside the US - 333 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong |
| FDA record | Open on fda.gov |