Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions...
FDA Recall #Z-1103-2013 — Class II — December 10, 2012
Product Description
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.
Reason for Recall
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.
Recalling Firm
Integra LifeSciences Corp. — Plainsboro, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11 XKnife V5.0.1 and 1 XKnife V5.0.2
Distribution
Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Code Information
Software Versions 5.0.1 and 5.0.2.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated