CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.
FDA device recall Z-2056-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.
- Action taken
- On April 16, 2008, the firm issued notifications via fedex to affected sites. In addition, installation and upgrade procedures will be updated to incorporate a step which decommissions sample beam data. If you have questions, contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or send and email to customersupport@accuray.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 109 units
- Distribution
- Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey, France, Italy, Spain, Greece and Germany.
- Date initiated
- 2008-04-09
- Date posted
- 2008-09-17
- Date terminated
- 2010-11-30
- 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 |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504) | Accuray Incorporated | 2007-09-21 |