Agency classClass IIOur severity:High FDA (Devices)·Z-0676-2020·Announced 2019-12-18

Viewray MRIdian Linac Radiation Therapy Systems Recalled for Missing Transfer Instructions

Viewray is recalling 24 MRIdian Linac Radiation Therapy Systems because the operator's manual and software lack adequate instructions for transferring treatment plans between systems.

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 involves a high-risk medical device (radiation therapy) where a lack of instructions could lead to improper treatment, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Viewray, Inc. is recalling 24 units of the MRIdian Linac Radiation Therapy System Model 10000 and 20000. The recall is due to an issue with transferring treatment regimens from one system to another. Specifically, adequate instructions for transferring treatment plans are not provided within the operator's manual or within the software operating system.

The affected devices are distributed in the United States (California, Florida, Illinois, Michigan, Missouri, New York, and Wisconsin) and internationally in Denmark, France, Germany, Italy, Japan, the Netherlands, Turkey, South Korea, and the United Arab Emirates. The specific serial numbers affected are 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, and 225. The Device Listing Numbers are D158423 and D297999.

Healthcare facilities and users of these systems should contact Viewray, Inc. for further instructions on how to proceed with the recall and to obtain the necessary guidance for safe operation.

The recalled product

Product: MRIdian Linac Radiation Therapy System Model 10000 and 20000
Manufacturer: Viewray, Inc.
Category: Medical Device — Radiation Therapy
Hazard: mis-labeling
improper-use
Affected units: 24

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 (20)

Serial Numbers: 100
101
102
103
104
105
107
108
112
113
201
202
203
204
205
206
209
211
213
214

Distribution

Distributed in 7 states:

Same manufacturer · Viewray, Inc.

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Same hazard · mis labeling