Viewray recalls
Viewray appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2021-06-16.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2015-05-13 to 2021-06-16 |
| By agency | FDA Device (12) |
| By classification | Class II (12) |
| By status | terminated (12) |
| Distribution named in notices | CA, FL, IL, MA, MI, MO, NY, US, WI |
Recalls
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiat…
FDA Device · Class II · 2021-06-16 · Viewray
Reason: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. - ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp…
FDA Device · Class II · 2020-12-02 · Viewray
Reason: 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. - ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input…
FDA Device · Class II · 2020-12-02 · Viewray
Reason: 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. - ViewRay System: Model No. 10000 and 20000 for radiation treatment
FDA Device · Class II · 2020-05-06 · Viewray
Reason: 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 TP… - MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA Device · Class II · 2019-12-18 · Viewray
Reason: 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. - MRIdian Linac Radiation Therapy System, Model 20000
FDA Device · Class II · 2019-05-08 · Viewray
Reason: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. - MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated f…
FDA Device · Class II · 2016-04-06 · Viewray
Reason: 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… - MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc
FDA Device · Class II · 2016-02-24 · Viewray
Reason: The system loaded a completion fraction in the incorrect order after a treatment interruption. - MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tum…
FDA Device · Class II · 2015-10-21 · Viewray
Reason: 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. - Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for le…
FDA Device · Class II · 2015-07-22 · Viewray
Reason: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. - Treatment Planning and Delivery System Software version 3.6. ViewRay
FDA Device · Class II · 2015-07-08 · Viewray
Reason: The software was failing to determine new patient locations if imaging is not enabled during treatment. - ViewRay System, Radiation Therapy System
FDA Device · Class II · 2015-05-13 · Viewray
Reason: 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.