Cuattro LLC: Medical Device Recall in 2020 - (Recall #: Z-1934-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 15, 2019

Date Posted: May 20, 2020

Recall Number: Z-1934-2020

Event ID: 85446

Reason for Recall:

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.

Status: Terminated

Product Quantity: 9 units

Code Information:

Product Version: 4.4.128

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated