Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700
FDA device recall Z-1862-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
- Action taken
- All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com for additional information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 105 units
- Distribution
- Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.
- Date initiated
- 2008-05-01
- Date posted
- 2008-09-16
- Date terminated
- 2010-11-30
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504) | Accuray Incorporated | 2007-09-21 |