Recall Z-1023-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Accuray Inc
Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | Feb 2, 2011 (initiated Jan 15, 2010) |
| Status | Terminated |
| Reason | When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available. |
| Root cause | Software design |
| Action | The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer |
| Quantity | 99 units |
| Distribution | Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc., May 1, 2009 |