Recall Z-1954-2015— Viewray Incorporated
Class II · Terminated
Class II FDA medical device recall by Viewray Incorporated, initiated 2015-05-07, terminated 2016-02-04. It names one FDA 510(k) clearance: K111862. Product: Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.. Reason: The software was failing to determine new patient locations if imaging is not enabled during treatment..
- Recalling firm
- Viewray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-07
- Terminated
- 2016-02-04
- Firm location
- Oakwood Village, OH, United States
510(k) clearances named in this recall
1 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
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
The software was failing to determine new patient locations if imaging is not enabled during treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.