CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatmen
FDA device recall Z-1008-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 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.
- Date initiated
- 2009-12-29
- Date posted
- 2011-02-01
- Date terminated
- 2011-02-11
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091146) | Accuray, Inc. | 2009-05-01 |