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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description Integra XKnifeĀ® 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.
Recall Number Z-1103-2013
Classification Class II
Code Info Software Versions 5.0.1 and 5.0.2.
Product Distributed Qty 11 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.

Event Detail

Event Id 63856
Product Type Devices
Status Ongoing
Recalling Firm Integra LifeSciences Corp.
City Plainsboro
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
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