RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufa
FDA device recall Z-0856-2009 · posted 2009-01-14 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- Product may not be tensioned properly, potentially causing unexpected rotation or descent.
- Action taken
- All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or customersupport@accuray.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 13 units
- Distribution
- Worldwide Distribution --- including USA and countries of France and Turkey.
- Date initiated
- 2008-10-30
- Date posted
- 2009-01-14
- Date terminated
- 2009-09-10
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146) | Accuray Incorporated | 2004-09-17 |