FDA Recall
Terminated
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.
Recall: Z-2085-2015
·
Initiated April 1, 2015
Recall
- Recall Number
- Z-2085-2015
- Event Number
- 71555
- Firm
- Viewray Incorporated
- FEI Number
- 3007546534
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software Design Change
- Initiated
- April 1, 2015
- Posted
- July 16, 2015
- Terminated
- February 4, 2016
- Address
- 2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536
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
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Action
ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at [email protected] or call the ViewRaylM Customer Support center at 855-286-8875.
Distribution
US Nationwide Distribution in the states of CA, MO & WI
Quantity
3