FDAJanuary 6, 2020device
ROSA Brain 3.0 Application-Brain
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
What to do
FDA enforcement status: Terminated
Brands named
medtech sasmedtech
UPCs
03760244031754
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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