Company:Viewray Incorporated
Date of Enforcement Report: 7/8/2015
Class lI:

PRODUCT

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

REASON
The firm discovered that the software was failing to determine new patient locations if imaging is not enable during treatment.

RECALLING FIRM/MANUFACTURER
Viewray Incorporated, Oakwood Village, OH on 5/7/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
Distributed in the states of CA, MO & WI.

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