RegWardenFDA facility compliance records
Recall

Class II — Viewray Incorporated

Recalling firmViewray Systems, Inc.
Registered facilityVIEWRAY SYSTEMS, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
ProductPatient 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.
Quantity3
DistributionUS Nationwide Distribution in the states of CA, MO & WI
Initiated2015-04-01
Classified2015-07-16
Terminated2016-02-04
Recall numberZ-2085-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Viewray Incorporated (Z-2085-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71555/

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