Z-0806-2016Class II

MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc

Name: Z-0806-2016 MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc
Creator: Viewray Incorporated
Published: 2015-12-24
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2015-12-24 / Terminated / root cause: software

FDA source

Viewray Incorporated began a recall of MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc on 2015-12-24. FDA classified it as Class II and gives the reason as "The system loaded a completion fraction in the incorrect order after a treatment interruption". 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-0806-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-24
Posted: 2016-02-12
Terminated: 2017-02-22
Recalling firm: Viewray Systems, Inc.
Product: MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The system loaded a completion fraction in the incorrect order after a treatment interruption.
Root cause tag: software
FDA root cause: Software design
Action: ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at [email protected] or call the ViewRay" Customer Support center at 855-286- 8875.
Quantity in commerce: 5 units
Distribution: US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
Product codes and lots: Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0806-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-12

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)