FDAOctober 15, 2019device
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
What to do
FDA enforcement status: Terminated
Brands named
cuattro
Recall history
No related federal recalls on record for this brand yet.
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