Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy sys
FDA device recall Z-1126-2013 · posted 2013-04-16 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
- Action taken
- On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 176 units
- Distribution
- Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Sp
- Date initiated
- 2013-03-19
- Date posted
- 2013-04-16
- Date terminated
- 2013-10-23
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137) | Accuray Incorporated | 2012-10-26 |