Z-1155-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2013
- Initiation Date
- March 27, 2013
- Termination Date
- August 20, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 devices are subject to correction.
Product Description
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.
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 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.
Code Information
Model number: 025007