Cuattro LLC recalls CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0

Recall date

October 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1934-2020

FDA classification

Class II

Brand / firm

Cuattro LLC

Sold / distributed

US: NJ, MI, SC, NC, MI, AR, OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0