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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