FDA-Device2013-04-24Class II
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.
Integra LifeSciences Corp.
Hazard
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.
Sold states
Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Affected count
11 XKnife V5.0.1 and 1 XKnife V5.0.2
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2013Don't want to check this manually?
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