Date Initiated by Firm | March 27, 2013 |
Date Posted | April 20, 2013 |
Recall Status1 |
Terminated 3 on August 20, 2013 |
Recall Number | Z-1155-2013 |
Recall Event ID |
64809 |
510(K)Number | K042146 |
Product Classification |
Couch, radiation therapy, powered - Product Code JAI
|
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. |
Code Information |
Model number: 025007 |
Recalling Firm/ Manufacturer |
Accuray Incorporated 1310 Chesapeake Ter Sunnyvale CA 94089-1100
|
For Additional Information Contact | Joy M. Sacmar 408-716-4651 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAI
|