Device product
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
Z-1103-2013
Product summary
- Event
- Event 63856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 XKnife V5.0.1 and 1 XKnife V5.0.2
- Official record key
device-enforcement:Z-1103-2013
Official wording
Reason: Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
Code information: Software Versions 5.0.1 and 5.0.2.
Distribution pattern: Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Derived failure modes
-
Device software or design
software error