Company: Cuattro LLC
Date of Enforcement Report: 5/20/2020
Class II
PRODUCT
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Recall Number: Z-1934-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Cuattro LLC on 10/15/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
US Nationwide