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.
This recall has been terminated (originally issued January 11, 2011).
- Company
- Accuray Inc
- Recall Initiated
- July 21, 2009
- Posted
- January 11, 2011
- Terminated
- January 12, 2011
- Recall Number
- Z-0853-2011
- Quantity
- 26
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
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.
Lot / Code Info
RoboCouch model 025007
Root Cause
Device Design
Action Taken
Consignees were notified verbally about the issue when an inspection was scheduled.
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