Recall Z-0364-2008 ยท MUJ System, Planning, Radiation Therapy Treatment
Accuray Inc
Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.
| Date | Dec 12, 2007 (initiated Mar 21, 2007) |
| Status | Terminated |
| Reason | Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. |
| Root cause | Software design |
| Action | The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com. |
| Quantity | 25 units |
| Distribution | Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray Incorporated, Sep 14, 2005 |