Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning Recalled by Integra LifeSciences Corp. Due to Depending on the system configuration, a software error...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected 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.
Quantity: 11 XKnife V5.0.1 and 1 XKnife V5.0.2
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 9 states: ID, IL, LA, MA, NJ, NY, OH, PA, SD
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report