Z-1251-2019Class II

MRIdian Linac Radiation Therapy System, Model 20000

Name: Z-1251-2019 MRIdian Linac Radiation Therapy System, Model 20000
Creator: Viewray, Inc.
Published: 2019-03-18
License: https://open.fda.gov/license/

Viewray, Inc. / initiated 2019-03-18 / Terminated / root cause: software

FDA source

Viewray, Inc. began a recall of MRIdian Linac Radiation Therapy System, Model 20000 on 2019-03-18. FDA classified it as Class II and gives the reason as "A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur". 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-1251-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Posted: 2019-05-02
Terminated: 2022-06-16
Recalling firm: Viewray, Inc.
Product: MRIdian Linac Radiation Therapy System, Model 20000.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Root cause tag: software
FDA root cause: Software design
Action: An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019.
Quantity in commerce: 17 devices
Distribution: Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
Product codes and lots: Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code IYE

K170751Class IIMRIdian Linac System with 138-leaf CollimatorViewray, Incorporated / cleared 2017-06-07

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)