Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris
FDA device recall Z-0629-2009 · posted 2009-01-17 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
- Action taken
- An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes. Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 4 units
- Distribution
- Nationwide Distribution. Product was distributed to 4 medical facilities in the US.
- Date initiated
- 2008-11-14
- Date posted
- 2009-01-17
- Date terminated
- 2010-12-02
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504) | Accuray Incorporated | 2007-09-21 |