Recall Z-1155-2013— Accuray Incorporated

Name: FDA recall Z-1155-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-27

Class II · Terminated

Class II FDA medical device recall by Accuray Incorporated, initiated 2013-03-27, terminated 2013-08-20. It names one FDA 510(k) clearance: K042146. 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.. 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..

Recalling firm: Accuray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2013-03-27
Terminated: 2013-08-20
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042146 — ROBOCOUCH PATIENT SUPPORT SYSTEMAccuray Incorporated·cleared 2004-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.