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Viewray Incorporated Recalls
6 recalls on record · May 13, 2015 to April 6, 2016 · Medical Devices
Recalls by year
15
16
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:
April 6, 2016Medical DevicesFDA
Viewray Incorporated recalls MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ Sys
Hazard: When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
February 24, 2016Medical DevicesFDA
Viewray Incorporated recalls MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Hazard: The system loaded a completion fraction in the incorrect order after a treatment interruption.
October 21, 2015Medical DevicesFDA
Viewray Incorporated recalls MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiot
Hazard: ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
July 22, 2015Medical DevicesFDA
Viewray Incorporated recalls Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and preci
Hazard: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
July 8, 2015Medical DevicesFDA
Viewray Incorporated recalls Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and pr
Hazard: The software was failing to determine new patient locations if imaging is not enabled during treatment.
May 13, 2015Medical DevicesFDA
Viewray Incorporated recalls ViewRay System, Radiation Therapy System
Hazard: The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.