FDA-Device2019-05-01Class II
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 nec
Brainlab AG
Hazard
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.
Sold states
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.
Affected count
US - 164 units; Outside the US - 333
Manufactured in
Olof-palme-str. 9, N/A, Munich, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief