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
Check against the official notice below — it lists the full affected range.
Brainlab AG is recalling specific versions of its RT Elements software applications used in radiation therapy planning, including Cranial SRS, Spine SRS, Multiple Brain Mets SRS, and RT QA versions 1.0.0 and 1.5.0. The recall affects 164 units in the United States (distributed across 29 states) and 333 units internationally across numerous countries. The recalled software has the potential to calculate incorrect dose distributions under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card) in its default system setting.
The recall affects multiple software revisions and catalog numbers as specified by Brainlab, identified by their unique GTINs and model numbers. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Netherl Quantity: US - 164 units; Outside the US - 333 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-
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.