Z-1580-2015Class II

ViewRay System, Radiation Therapy System

Name: Z-1580-2015 ViewRay System, Radiation Therapy System
Creator: Viewray Incorporated
Published: 2015-01-15
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2015-01-15 / Terminated / root cause: software

FDA source

Viewray Incorporated began a recall of ViewRay System, Radiation Therapy System on 2015-01-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1580-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Posted: 2015-05-05
Terminated: 2015-09-23
Recalling firm: Viewray Systems, Inc.
Product: ViewRay System, Radiation Therapy System
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.
Quantity in commerce: 1
Distribution: US distribution to MO.
Product codes and lots: M/N 10000, S/N 100 only

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1580-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1580-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-05

Product code IYE

K111862Class IIViewray SystemViewray, Incorporated / cleared 2012-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)