Home / Recalls / Viewray, Inc. / Z-1251-2019

Z-1251-2019 Class II Terminated

Recalled by Viewray, Inc. — Mountain View, CA

Recall Details

Product Type
Devices
Report Date
May 8, 2019
Initiation Date
March 18, 2019
Termination Date
June 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 devices

Product Description

MRIdian Linac Radiation Therapy System, Model 20000.

Reason for Recall

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

Distribution Pattern

Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

Code Information

Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.

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-0676-2020 Class II — MRIdian Linac Radiation Therapy System Model 10000 and 20000 (March 3, 2019)