Z-1836-2021Class II

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 -

Name: Z-1836-2021 ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 -
Creator: Viewray, Inc.
Published: 2021-05-04
License: https://open.fda.gov/license/

Viewray, Inc. / initiated 2021-05-04 / Terminated / root cause: software

FDA source

Viewray, Inc. began a recall of ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon... on 2021-05-04. FDA classified it as Class II and gives the reason as "Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software". 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-1836-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-04
Posted: 2021-06-09
Terminated: 2023-10-19
Recalling firm: Viewray, Inc.
Product: ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Root cause tag: software
FDA root cause: Software design
Action: On May 2021, ViewRay issued an "Urgent Medical Device Correction" notification to all affected consignees via E-Mail. All affected consignees were outside of the US. In addition to informing consignees about the recall, ViewRay asked customers to take the following actions: 1. We will provide an update to customers when new information is available. Until that time: 2. Customers should be aware of these software anomalies and the behavior of the system described in this letter. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification. 4. Any device-related incidents should be reported to ViewRay, ViewRays distributor or local representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the Competent Authority if appropriate or to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 5. If you have any questions related to this letter, please contact ViewRay Customer Support at [email protected] or call +1 855-286-8875 toll free 24 hours a day, 7 days a week.
Quantity in commerce: 8 versions
Distribution: International distribution only to the countries of France, Germany, Italy, and Switzerland.
Product codes and lots: French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1836-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1836-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code MUJ

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)