Recall Z-1580-2015— Viewray Incorporated

Name: FDA recall Z-1580-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Class II · Terminated

Class II FDA medical device recall by Viewray Incorporated, initiated 2015-01-15, terminated 2015-09-23. It names one FDA 510(k) clearance: K111862. Product: ViewRay System, Radiation Therapy System. 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..

Recalling firm: Viewray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Terminated: 2015-09-23
Firm location: Oakwood Village, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K111862 — VIEWRAY SYSTEMViewray, Incorporated·cleared 2012-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ViewRay System, Radiation Therapy System

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.