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 indicated. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 indicated.
Brand
Accuray Inc
Lot Codes / Batch Numbers
All systems with multiplan tratment planning system software version 3.5
Products Sold
All systems with multiplan tratment planning system software version 3.5
Accuray Inc is recalling CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, wit due to 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 cor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026