Recall Z-1103-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Integra LifeSciences Corp.
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.
| Date | Apr 12, 2013 (initiated Dec 10, 2012) |
| Status | Terminated |
| Reason | 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 | 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 Acknowled |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100417 | XKNIFE 5 Integra Radionics, Inc., Apr 8, 2010 |