FDAFDA · Food and drugs·Recall number Z-1103-2013
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.
Published April 24, 2013 · Recall initiated: December 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
- Lot
- Software Versions 5.0.1 and 5.0.2.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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