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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
see related information
Date Posted April 12, 2013
Recall Status1 Terminated on August 01, 2013
Recall Number Z-1103-2013
Recall Event ID 63856
Premarket Notification
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.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
Consumer Instructions Contact the recalling firm for information
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.
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 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 and Original Applicant = INTEGRA RADIONICS, INC.
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