—#114917

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.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K100417
Affected lot / code info: Software Versions 5.0.1 and 5.0.2.

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.

Root cause (FDA determination)

Software design

Action the firm took

Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

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

Timeline

Recall initiated: 2012-12-10
Posted by FDA: 2013-04-12
Terminated: 2013-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.