Device evidence

device-recall:cfres:131428

AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Official recall number

Z-0464-2015

Evidence summary

Product code: IYE
Recall status: Terminated
Event initiated: October 15, 2014
Root cause: Software in the Use Environment
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0464-2015