Recall Z-2085-2015— Viewray Incorporated
Class II · Terminated
Class II FDA medical device recall by Viewray Incorporated, initiated 2015-04-01, terminated 2016-02-04. It names one FDA 510(k) clearance: K111862. Product: Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.. Reason: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot..
- Recalling firm
- Viewray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-01
- 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
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.