RegWardenFDA facility compliance records
Company

Viewray Systems, Inc.

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 5 recalls; 2016: 1 recalls52015120162017201820192020202120222023202420252026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2016-03-07
    When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initia…
  • Class IITerminated2015-12-24
    The system loaded a completion fraction in the incorrect order after a treatment interruption.
  • Class IITerminated2015-08-27
    ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
  • Class IITerminated2015-05-07
    The software was failing to determine new patient locations if imaging is not enabled during treatment.
  • Class IITerminated2015-04-01
    ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
  • Class IITerminated2015-01-15
    The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Viewray Systems, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10090487-viewray-systems-inc/

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