Recall – X-ray system software may display incorrect patient image

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.