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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- 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
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