medical Class II Updated 2019-12-18

Viewray, Inc. recalls MRIdian Linac Radiation Therapy System Model 10000 and 20000

Recalled Product

MRIdian Linac Radiation Therapy System Model 10000 and 20000


Hazard / Issue

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

Issued by

FDA

Affected States: CA, FL, IL, MI, MO, NY, WI
Lot/Code Info: Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999
View official government recall

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