Date of Enforcement Report: 7/8/2015
Treatment Planning and Delivery System Software version 3.6. ViewRay” Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Recall Number Z-1954-2015
The firm discovered that the software was failing to determine new patient locations if imaging is not enable during treatment.
Viewray Incorporated, Oakwood Village, OH on 5/7/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Distributed in the states of CA, MO & WI.