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.
Reported: May 1, 2013 Initiated: March 27, 2013 #Z-1155-2013
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.
Details
- Recalling Firm
- Accuray Incorporated
- Units Affected
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accuray Incorporated. Units affected: 16 devices are subject to correction..
Why was this product recalled? ▼
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2013. Severity: Moderate. Recall number: Z-1155-2013.
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