Cl II Viewray Patient Handling System software

Company:Viewray Incorporated
Date of Enforcement Report: 7/22/2015
Class lI:

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER
Viewray Incorporated, Oakwood Village, OH on 4/1/2015 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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.