Home / Recalls / Viewray, Inc. / Z-1836-2021

Z-1836-2021 Class II Terminated

Recalled by Viewray, Inc. — Mountain View, CA

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
May 4, 2021
Termination Date
October 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 versions

Product Description

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

Reason for Recall

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

Distribution Pattern

International distribution only to the countries of France, Germany, Italy, and Switzerland.

Code Information

French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244

Other recalls by Viewray, Inc.

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