Z-0115-2016Class II

MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision...

Name: Z-0115-2016 MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision...
Creator: Viewray Incorporated
Published: 2015-08-27
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2015-08-27 / Terminated / root cause: design

FDA source

Viewray Incorporated began a recall of MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions... on 2015-08-27. FDA classified it as Class II and gives the reason as "ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0115-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-10-09
Terminated: 2017-06-09
Recalling firm: Viewray Systems, Inc.
Product: MRIdian ViewRay Radiation Therapy System, ViewRay Is 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: ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Root cause tag: design
FDA root cause: Device Design
Action: ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. 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: 4 units
Distribution: US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Product codes and lots: Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0115-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09

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)