Z-0676-2020Class II

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Name: Z-0676-2020 MRIdian Linac Radiation Therapy System Model 10000 and 20000
Creator: Viewray, Inc.
Published: 2019-03-03
License: https://open.fda.gov/license/

Viewray, Inc. / initiated 2019-03-03 / Terminated / root cause: labeling and UDI

FDA source

Viewray, Inc. began a recall of MRIdian Linac Radiation Therapy System Model 10000 and 20000 on 2019-03-03. FDA classified it as Class II and gives the reason as "Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0676-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-03
Posted: 2019-12-12
Terminated: 2021-04-28
Recalling firm: Viewray, Inc.
Product: MRIdian Linac Radiation Therapy System Model 10000 and 20000
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 03/03/2019, the firm emailed an "URGENT DEVICE RECALL" to customers to inform them of a safety issue with the Treatment Planning and Delivery System (TPDS) in the MRIdian System. The notice explained that when a partially-completed patient treatment regiment is moved to their system from another system, the use needs to rescale the plan. The TPDS does not automatically rescale the treatment plan. The customers are instructed: If they want to move a treatment plan from one system to another and still show the total original prescribed dose on the MRIdian TPDS the customer will have multiple ways to do this. 1. Once the user/operator has evaluated the plan at the full dose, ensure the prescription matches the dose and number of fractions to be delivered on the MRIdian, and scale the dose to the target by either renormalizing or changing the target objective in the optimizer. 2. Keep the original total number of fractions (including those delivered elsewhere) in the prescription but when the plan is assigned to the fractions in the delivery calendar, Discontinue the number of fractions that have already been delivered on another system. 3. Import the previously delivered dose files as a RTDose and fuse with the plan images. Optimize to the remaining target dose that is to be deliver on MRIdian. Include the imported dose as Previously Delivered Dose and Calculate in the Finish screen to display the full dose which has and will be delivered. Ensure the prescription matches the dose and number of fractions to be delivered on the MRIdian. 4. Import the previously delivered dose files as RTDose and fuse with the plan images. Optimize to the original total dose, including the Previously Delivered Dose as part of the optimization. Ensure the prescription matches the total dose and number of fractions including those treated elsewhere and those to be delivered on the MRIdian. The customer is also informed that the Recalling Firm will address this is
Quantity in commerce: 24 Systems
Distribution: US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
Product codes and lots: Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0676-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0676-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code IYE

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)