Integra LifeSciences Corp.: Medical Device Recall in 2013 - (Recall #: Z-1103-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 10, 2012

Date Posted: April 24, 2013

Recall Number: Z-1103-2013

Event ID: 63856

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 XKnife V5.0.1 and 1 XKnife V5.0.2

Code Information:

Software Versions 5.0.1 and 5.0.2.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated