Viewray Incorporated: Medical Device Recall in 2015 - (Recall #: Z-1580-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ViewRay System, Radiation Therapy System

Product Classification:

Class II

Date Initiated: January 15, 2015

Date Posted: May 13, 2015

Recall Number: Z-1580-2015

Event ID: 71050

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1

Code Information:

M/N 10000, S/N 100 only

Distribution Pattern:

US distribution to MO.

Voluntary or Mandated:

Voluntary: Firm initiated