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 stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
- Recall Initiated
- March 11, 2019
- Terminated
- May 12, 2021
- Recall Number
- Z-1205-2019
- Quantity
- US - 164 units; Outside the US - 333
Reason for Recall
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.
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, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom.
Lot / Code Info
Software revisions of affected RT Elements applications: - 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 Unique Identifier (UDI): GTIN for affected product(s): Cranial SRS 1.0 -7 04056481000554 Cranial SRS 1.5 -704056481140403 Spine SRS 1.0 - 04056481000547 Spine SRS 1.5 - 04056481140380 Multiple Brain Mets SRS 1.5 7 04056481006853 RT QA 1.0 -7 04056481007119 RT QA 1.5 -7 04056481140397 Model/catalogue numbers: 21702A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-04C ELEMENTS MULTIPLE BRAIN METS SRS INST 21702-0 6 ELEMENTS MULTIPLE BRAIN METS SRS LICENSE 21702-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-36A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21702-60A ELEMENTS MULTIPLE BRAIN METS SRS SUB. 21712A ELEMENTS MULTIPLE BRAIN METS SRS 21722A ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC 21722-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC 21741A UPD TO ELEMENTS BRAIN MET PLAN 21742 ELEMENTS CRANIAL SRS 21742A ELEMENTS CRANIAL SRS 21743 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743A ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-01 ELEMENTS CRANIAL SRS LICENSE ELEMENTS CRANIAL SRS LICENSE 1.5 ELEMENTS CRANIAL SRS INSTALLER 21743-02A ELEMENTS CRANIAL SRS INSTALLER 1.5 21743-12 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-36 ELEMENTS CRANIAL SRS SUBSCRIPTION 21743-60 ELEMENTS CRANIAL SRS SUBSCRIPTION 21744 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744A ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-12 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-36 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21744-60 ELEMENTS CRANIAL SRS SUBSCRIPTION FOC 21745 ELEMENTS CRANIAL SRS (UPD) 21745A ELEMENTS CRANIAL SRS (UPD) 21747 ELEMENTS SPINE SRS 21747A ELEMENTS SPINE SRS 21748 ELEMENTS SPINE SRS SUBSCRIPTION 21748A ELEMENTS SPINE SRS SUBSCRIPTION 21748-01 ELEMENTS SPINE SRS LICENSE ELEMENTS SPINE SRS LICENSE 1.5 ELEMENTS SPINE SRS INSTALLER 21748-02A ELEMENTS SPINE SRS INSTALLER 1.5 21748-12 ELEMENTS SPINE SRS SUBSCRIPTION 21748-36 ELEMENTS SPINE SRS SUBSCRIPTION 21748-60 ELEMENTS SPINE SRS SUBSCRIPTION 21749 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749A ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-12 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-36 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21749-60 ELEMENTS SPINE SRS SUBSCRIPTION FOC 21750 ELEMENTS SPINE SRS (UPD) 21750A ELEMENTS SPINE SRS (UPD) 21762 RT QA 1.0 21762A RT QA 1.5 21762-01 RT QA LICENSE RT QA LICENSE 1.5 RT QA INSTALLER 21762-02A RT QA INSTALLER 1.5
Root Cause
Device Design
Action Taken
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.