FDAFDA · Food and drugs·Recall number Z-1155-2013
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.
Published May 1, 2013 · Recall initiated: March 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accuray Incorporated
- Distributor
- 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.
- Lot
- Model number: 025007
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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