CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Resp
FDA device recall Z-0035-2012 · posted 2011-10-11 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.
- Action taken
- Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 236 total devices
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-09-12
- Date posted
- 2011-10-11
- Date terminated
- 2012-02-27
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K102650) | Accuray Incorporated | 2010-11-17 |