Stereotactic Irradiation System

• Terminated Z-2137-2008 FDA Unclassified (pre-2012) ·initiated 18 Jun 2008

A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.

• Terminated Z-1146-2007 FDA Unclassified (pre-2012) ·initiated 7 Apr 2006

This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.

• Terminated Z-1145-2007 FDA Unclassified (pre-2012) ·initiated 2 Jan 2006

Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.

• Terminated Z-1147-2007 FDA Unclassified (pre-2012) ·initiated 31 May 2005

When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.

• Terminated Z-1152-2007 FDA Unclassified (pre-2012) ·initiated 28 Apr 2005

When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.

• Terminated Z-1153-2007 FDA Unclassified (pre-2012) ·initiated 11 Apr 2005

When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.

• Terminated Z-1154-2007 FDA Unclassified (pre-2012) ·initiated 30 Dec 2004

When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.

• Terminated Z-1155-2007 FDA Unclassified (pre-2012) ·initiated 30 Nov 2004

When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.