Recall Z-1155-2013 ยท JAI Couch, Radiation Therapy, Powered
Accuray Incorporated
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.
| Date | Apr 20, 2013 (initiated Mar 27, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 16 devices are subject to correction. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM Accuray Incorporated, Sep 17, 2004 |