RT QA 1.5Recalls & reported problems
Brainlab SE · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 11, 2019Terminated
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.
Z-1205-2019 · Root cause: Device Design · FDA record ↗
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- RayStation 9B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.