Date of Enforcement Report: 7/22/2015
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.
Recall Number Z-2085-2015
ViewRay” received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Viewray Incorporated, Oakwood Village, OH on 4/1/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Distributed in the states of CA, MO & WI.