Recall Z-0853-2011
Accuray Inc · initiated July 21, 2009
Product
RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
Codes / lots: RoboCouch model 025007
Reason for recall
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
FDA-determined cause: Device Design
Action taken
Consignees were notified verbally about the issue when an inspection was scheduled.
Details
- Recall number
- Z-0853-2011
- Initiated
- July 21, 2009
- Posted by FDA
- January 11, 2011
- Terminated
- January 12, 2011
- Product code
- JAI – Couch, Radiation Therapy, Powered
- Quantity
- 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.
- Recalling firm
- Accuray Inc, Sunnyvale, CA