XKNIFE 5.0 INSTALL KIT
Received Nov 16, 2012
Report 1222895-2012-00048 · MDR key 2845265
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
"X1 AND Y1 JAWS SHOWING AS -3.5 IN (B)(4), SHOULD BE +3.5 DUE TO SOFTWARE ERROR." THE ERROR MESSAGE OCCURS IN THE (B)(4) SYSTEM. THE (B)(4) SYSTEM IS THIRD PARTY SOFTWARE INTEGRATED WITH THE LINAC THAT VERIFIES THE PROPER POSITION OF THE COUCH, COLLIMATOR, GANTRY AND ANY BEAM MODIFIERS BEFORE TREATMENT IS DELIVERED. XKNIFE IS A RADIOSURGERY AND RADIOTHERAPY TREATMENT PLANNING SYSTEM INTENDED FOR USE IN STEREOTACTIC AND NON-STEREOTACTIC (FRAMELESS STEREOTACTIC), COLLIMATED BEAM, COMPUTER PLANNED, LINEAR ACCELERATOR (LINAC) BASED TREATMENT. THE SOFTWARE INSTALLATION IS CONDUCTED PRIOR TO SCHEDULING THE USE OF THE SYSTEM TO TREAT PATIENTS. THEREFORE, THERE WAS NO PATIENT CONTACT.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.