Home / Recalls / Viewray, Inc. / Z-0676-2020

Z-0676-2020 Class II Terminated

Recalled by Viewray, Inc. — Mountain View, CA

Recall Details

Product Type
Devices
Report Date
December 18, 2019
Initiation Date
March 3, 2019
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 Systems

Product Description

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Reason for Recall

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.

Distribution Pattern

US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

Code Information

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

Other recalls by Viewray, Inc.

  • Z-1836-2021 Class II — ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usa (May 4, 2021)
  • Z-0482-2021 Class II — ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/4 (October 20, 2020)
  • Z-0481-2021 Class II — ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC (October 20, 2020)
  • Z-1803-2020 Class II — ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRI (November 18, 2019)
  • Z-1251-2019 Class II — MRIdian Linac Radiation Therapy System, Model 20000. (March 18, 2019)