Z-2085-2015 Class II Terminated

Recalled by Viewray Incorporated — Oakwood Village, OH

Recall Details

Product Type
Devices
Report Date
July 22, 2015
Initiation Date
April 1, 2015
Termination Date
February 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Model #10000, Serial #'s: 100, 101, and 102