CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report

MRIdian System recalled by Viewray

Viewray is recalling ViewRay MRIdian System, distributed nationwide in the US. The recall was initiated on 20 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots/Serial Numbers

Quantity recalled3 systems

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-0481-2021
FDA event ID: 86661
Recalling firm: Viewray, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2020
FDA classified: 20 Nov 2020
Reported: 2 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Imaging Equipment

Timeline

20 Oct 2020	Recall initiated by company
20 Nov 2020	Classified by FDA	+31 days
2 Dec 2020	Published in enforcement report	+12 days

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

Reason for recall

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.

Nationwide California Florida Illinois Michigan Missouri New York Oregon Wisconsin

Questions about this recall

Is MRIdian System recalled?

Yes. Viewray recalled MRIdian System on 20 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0481-2021.

Why was it recalled?

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

Which lots are affected?

All Lots/Serial Numbers

Where was it sold?

Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.

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
6 May 2020Device	CLASS II	ViewRay System: Model No. 10000 and 20000 for radiation treatment. recalled	Viewray	Device Malfunction	8 states
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

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals