Device evidence

device-recall:cfres:131533

adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.

Official recall number

Z-0836-2015

Evidence summary

Product code: LHN
Recall status: Terminated
Event initiated: November 07, 2014
Root cause: Software design (manufacturing process)
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0836-2015