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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:129687

Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.

Official recall number

Z-0325-2016

Evidence summary

Product code
LNH
Recall status
Terminated
Event initiated
August 21, 2014
Root cause
Software Design Change
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0325-2016

Field note

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