CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, version
FDA device recall Z-1098-2012 · posted 2012-02-23 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
- Action taken
- Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 207
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece
- Date initiated
- 2012-01-16
- Date posted
- 2012-02-23
- Date terminated
- 2012-09-28
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091999) | Accuray, Inc. | 2009-09-18 |