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
ReasonThe system loaded a completion fraction in the incorrect order after a treatment interruption.
ProductMRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Quantity5 units
DistributionUS Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
Initiated2015-12-24
Classified2016-02-12
Terminated2017-02-22
Recall numberZ-0806-2016
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-0806-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73086/

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