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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:127292

Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

Official recall number

Z-1700-2014

Evidence summary

Product code
MUE
Recall status
Terminated
Event initiated
May 13, 2014
Root cause
Component change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1700-2014