Reported May 1, 2013 · Terminated
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient…
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1310 Chesapeake Ter · Sunnyvale, CA · 94089-1100
Is this the product you have?
- RoboCouch Patient
- Positioning System Product Usageis 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
- Lot codes and dates
- Model number025007
- Amount recalled
- 16 devices are subject to correction.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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