CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report

ViewRay System: Model No. 10000 and 20000 for radiation treatment. recalled

Viewray is recalling ViewRay System, distributed in 8 states. The recall was initiated on 18 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled32

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1803-2020
FDA event ID: 85441
Recalling firm: Viewray, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2019
FDA classified: 27 Apr 2020
Reported: 6 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

18 Nov 2019	Recall initiated by company
27 Apr 2020	Classified by FDA	+161 days
6 May 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

Where it was distributed

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.

California Florida Illinois Massachusetts Michigan Missouri New York Wisconsin

Questions about this recall

Is ViewRay System: Model No. 10000 and 20000 for radiation treatment. recalled?

Yes. Viewray recalled ViewRay System: Model No. 10000 and 20000 for radiation treatment. on 18 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-1803-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Viewray

All 6

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021Device	CLASS II	MRIdian Linac System recalled by Viewray	Viewray	Device Malfunction	Nationwide
2 Dec 2020Device	CLASS II	MRIdian Linac System recalled by Viewray	Viewray	Temperature Abuse	Nationwide
2 Dec 2020Device	CLASS II	MRIdian System recalled by Viewray	Viewray	Temperature Abuse	Nationwide
18 Dec 2019Device	CLASS II	MRIdian Linac Radiation Therapy System recalled by Viewray	Viewray	Device Malfunction	7 states
8 May 2019Device	CLASS II	MRIdian Linac Radiation Therapy System recalled by Viewray	Viewray	Other	6 states

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