Reported Apr 24, 2013 · Terminated
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2.…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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.
- Lot codes and dates
- Software Versions 5.0.1 and 5.0.2.
- Amount recalled
- 11 XKnife V5.0.1 and 1 XKnife V5.0.2
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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