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Recall Observatory FDA recall evidence

Device product

ViewRay System, Radiation Therapy System

Z-1580-2015

January 15, 2015

Class II

Product summary

Firm
Viewray Incorporated
Event
Event 71050
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1580-2015

Official wording

Reason: 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.

Code information: M/N 10000, S/N 100 only

Distribution pattern: US distribution to MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.