RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufa
FDA device recall Z-0853-2011 · posted 2011-01-11 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
- Action taken
- Consignees were notified verbally about the issue when an inspection was scheduled.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 26
- Distribution
- Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.
- Date initiated
- 2009-07-21
- Date posted
- 2011-01-11
- Date terminated
- 2011-01-12
- 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 |
| ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146) | Accuray Incorporated | 2004-09-17 |