Z-1103-2013Class II

Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and...

Name: Z-1103-2013 Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and...
Creator: Integra LifeSciences Corp.
Published: 2012-12-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-12-10 / Terminated / root cause: software

FDA source

Integra LifeSciences Corp. began a recall of Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and... on 2012-12-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1103-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-10
Posted: 2013-04-12
Terminated: 2013-08-01
Recalling firm: Integra LifeSciences Corporation
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 11 XKnife V5.0.1 and 1 XKnife V5.0.2
Distribution: Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Product codes and lots: Software Versions 5.0.1 and 5.0.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1103-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-12

Product code MUJ

K100417Class IIXknife 5Integra Radionics, Inc. / cleared 2010-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)