Viewray Incorporated recalls Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision…

Recall date

April 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2085-2015

FDA classification

Class II

Brand / firm

Viewray Incorporated

Sold / distributed

US Nationwide Distribution in the states of CA, MO & WI

Why it was recalled

ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.