Recall Z-1580-2015 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
ViewRay System, Radiation Therapy System
| Date | May 5, 2015 (initiated Jan 15, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software Design Change |
| Action | On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position. |
| Quantity | 1 |
| Distribution | US distribution to MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111862 | VIEWRAY SYSTEM Viewray, Incorporated, May 22, 2012 |