Recall Z-1836-2021— Viewray, Inc.
Class II · Terminated
Class II FDA medical device recall by Viewray, Inc., initiated 2021-05-04, terminated 2023-10-19. It names 2 FDA 510(k) clearances: K181989, K102915. Product: 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: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software..
- Recalling firm
- Viewray, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-04
- Terminated
- 2023-10-19
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.