The Recall Desk
ModerateFDA (Devices)·Z-1103-2013·Announced 2013-04-24

Integra XKnife Software Versions 5.0.1 and 5.0.2 Recalled for Beam Plan Error

Integra LifeSciences Corp. is recalling XKnife software versions 5.0.1 and 5.0.2 due to a software error that may occur when transmitting beam plans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a risk of temporary or medically reversible health consequences. The source text describes a software error message but does not report any injuries, illnesses, or fatalities, aligning with a moderate severity level.

Plain-English summary

Integra LifeSciences Corp. is recalling 12 units of Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning software, specifically versions 5.0.1 and 5.0.2. The recall involves 11 units of version 5.0.1 and 1 unit of version 5.0.2. These software versions are intended for use in stereotactic and non-stereotactic, collimated beam, computer-planned, linear accelerator-based treatment.

The recall is being issued because a software error message may occur in these versions if a beam plan is transmitted from XKnife using DICOM-RT, depending on the system configuration. The affected software was distributed in the states of Illinois, Idaho, Louisiana, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, and South Dakota.

This is a Class II recall, which means the product may cause temporary or medically reversible health consequences. No specific instructions for consumers are provided in the source text, but the recalling firm is responsible for managing the recall.

The recalled product

Product
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.
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Radiation Therapy Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software Versions 5.0.1 and 5.0.2.

Distribution

Distributed in 9 states:

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