Z-1954-2015Class II

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery...

Name: Z-1954-2015 Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery...
Creator: Viewray Incorporated
Published: 2015-05-07
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2015-05-07 / Terminated / root cause: software

FDA source

Viewray Incorporated began a recall of Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors... on 2015-05-07. FDA classified it as Class II and gives the reason as "The software was failing to determine new patient locations if imaging is not enabled during treatment". 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-1954-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-07
Posted: 2015-07-02
Terminated: 2016-02-04
Recalling firm: Viewray Systems, Inc.
Product: Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The software was failing to determine new patient locations if imaging is not enabled during treatment.
Root cause tag: software
FDA root cause: Software design
Action: On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.
Quantity in commerce: 3
Distribution: Distributed in the states of CA, MO & WI.
Product codes and lots: Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1954-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

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)