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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:141165

The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Official recall number

Z-0225-2016

Evidence summary

Product code
LLZ
Recall status
Terminated
Event initiated
September 28, 2015
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0225-2016

Field note

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