Z-1803-2020Class II

ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning...

Name: Z-1803-2020 ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning...
Creator: Viewray, Inc.
Published: 2019-11-18
License: https://open.fda.gov/license/

Viewray, Inc. / initiated 2019-11-18 / Terminated / root cause: software

FDA source

Viewray, Inc. began a recall of ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software on 2019-11-18. FDA classified it as Class II and gives the reason as "Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian...". 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-1803-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2020-04-27
Terminated: 2023-02-22
Recalling firm: Viewray, Inc.
Product: ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
Root cause tag: software
FDA root cause: Software design
Action: On 11/18/2019, the firm send an "Urgent Device Correction" letter to customers via email to inform them firm has become aware of an issue impacting the MRIdian System Treatment Planning and Delivery System (TPDS) software. The issue relates to an optional feature related to using previously delivered dose to make a new plan on MRIdian. The firm determined that in some cases dose previously delivered to a patient may not be accurately registered with a daily scan. The firm is instructing its customers to: 1) Do not: Sum previously delivered treatment plans in the treatment delivery workflow as it could result in delivery of a higher or lower dose. 2) Do not: proceed with plan summation if this issue is observed in planning workflow. 3) Do: contact ViewRay Customer Support for assistance when summing plans in the treatment planning workflow. ViewRay is developing a resolution for this issue. You will be contacted by VewRay Customer Support when a software resolution is available. If you have any questions, please do not hesitate to contact ViewRay Customer Support at [email protected] or call +1 855-286-8875.
Quantity in commerce: 32
Distribution: Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.
Product codes and lots: Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1803-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1803-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-27

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)