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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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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
Distribution Pattern Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Software Versions 5.0.1 and 5.0.2. Class II 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. 11 XKnife V5.0.1 and 1 XKnife V5.0.2 Z-1103-2013