Recall Z-1008-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Accuray Inc
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indi
| Date | Feb 1, 2011 (initiated Dec 29, 2009) |
| Status | Terminated |
| Reason | If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment. |
| Root cause | Employee error |
| Action | The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated December 29, 2009, to all customers. The letter described the product, problem, and action to be taken by the customers. The customers were instructed to verify correctness of the CT number to relative electron density and Mass Density Calibration curves. Note: A patch is being developed to address this issue. Accuray Customer Support will contact the customers regarding further resolution. If you have any questions or concerns regarding this issue, please contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-40 |
| Quantity | 71 units are subject to this action |
| Distribution | Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China. |
| 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 |