Device product
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.
Z-1155-2013
Product summary
- Event
- Event 64809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 devices are subject to correction.
- Official record key
device-enforcement:Z-1155-2013
Official wording
Reason: A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Code information: Model number: 025007
Distribution pattern: 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.
Derived failure modes
-
Unknown
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.