RoboCouch Patient Positioning System Product Usage: is 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 April 20, 2013).
- Company
- Accuray Incorporated
- Recall Initiated
- March 27, 2013
- Posted
- April 20, 2013
- Terminated
- August 20, 2013
- Recall Number
- Z-1155-2013
- Quantity
- 16 devices are subject to correction.
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Distribution
Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
Lot / Code Info
Model number: 025007
Root Cause
Nonconforming Material/Component
Action Taken
Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667