Class 2 Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning

• Date Initiated by Firm: December 10, 2012
• Date Posted: April 12, 2013
• Recall Status: Terminated on August 01, 2013
• Recall Number: Z-1103-2013
• Recall Event ID: 63856
• 510(K)Number: K100417
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• 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.
• Code Information: Software Versions 5.0.1 and 5.0.2.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: 609-275-0500
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUJ