Z-1309-2016Class II

MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the...

Name: Z-1309-2016 MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the...
Creator: Viewray Incorporated
Published: 2016-03-07
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2016-03-07 / Terminated / root cause: software

FDA source

Viewray Incorporated began a recall of MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic... on 2016-03-07. FDA classified it as Class II and gives the reason as "When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a...". 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-1309-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-07
Posted: 2016-03-31
Terminated: 2017-02-22
Recalling firm: Viewray Systems, Inc.
Product: MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) 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: When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
Root cause tag: software
FDA root cause: Software design
Action: ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed 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: Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
Product codes and lots: Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

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)