Device evidence

device-recall:cfres:118713

GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.

Official recall number

Z-1519-2013

Evidence summary

Product code: MUE
Recall status: Terminated
Event initiated: January 14, 2013
Root cause: Radiation Control for Health and Safety Act
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1519-2013