Z-2085-2015Class II

Patient Handling System (Motion Control Software)

Name: Z-2085-2015 Patient Handling System (Motion Control Software)
Creator: Viewray Incorporated
Published: 2015-04-01
License: https://open.fda.gov/license/

Viewray Systems, Inc. / initiated 2015-04-01 / Terminated / root cause: software

FDA source

Viewray Incorporated began a recall of Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and... on 2015-04-01. FDA classified it as Class II and gives the reason as "ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot". 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-2085-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-01
Posted: 2015-07-16
Terminated: 2016-02-04
Recalling firm: Viewray Systems, Inc.
Product: Patient Handling System (Motion Control Software), Product Usage: 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 received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Root cause tag: software
FDA root cause: Software Design Change
Action: ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at [email protected] or call the ViewRaylM Customer Support center at 855-286-8875.
Quantity in commerce: 3
Distribution: US Nationwide Distribution in the states of CA, MO & WI
Product codes and lots: Model #10000, Serial #'s: 100, 101, and 102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2085-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-16

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)