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.
FDA Recall Z-1103-2013 · Posted 2013-04-12
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2012-12-10
Date Terminated2013-08-01
Product Quantity11 XKnife V5.0.1 and 1 XKnife V5.0.2
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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