The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0481-2021·Announced 2020-12-02

ViewRay MRIdian System Recalled for Potential Burn Injury Risk

ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (burn injury) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

ViewRay, Inc. is recalling three ViewRay MRIdian Systems (Model No. 10000) due to a potential safety hazard. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is issued because there is a potential that components of the receive coil can reach elevated temperatures. This condition has the potential to cause a burn injury to the patient or user. The affected systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The recalled units were distributed worldwide, including in the United States (California, New York, Florida, Illinois, Michigan, Missouri, Oregon, and Wisconsin) and in France, Germany, Italy, the United Kingdom, Taiwan, the Netherlands, Israel, and Denmark. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product
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…
Manufacturer
Viewray, Inc.
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots/Serial Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Viewray, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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