Viewray Recalls
6 recalls on record · May 8, 2019 to June 16, 2021 · Medical Devices
Recalls by year
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
June 16, 2021Medical DevicesFDA
Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning ex
Hazard: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
December 2, 2020Medical DevicesFDA
Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50
Hazard: There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
December 2, 2020Medical DevicesFDA
Viewray, Inc. recalls ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz
Hazard: There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
May 6, 2020Medical DevicesFDA
Viewray, Inc. recalls ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Deliv
Hazard: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
December 18, 2019Medical DevicesFDA
Viewray, Inc. recalls MRIdian Linac Radiation Therapy System Model 10000 and 20000
Hazard: 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.
May 8, 2019Medical DevicesFDA
Viewray, Inc. recalls MRIdian Linac Radiation Therapy System, Model 20000.
Hazard: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.