Recall Z-1934-2020— Cuattro LLC

Name: FDA recall Z-1934-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-15

Class II · Terminated

Class II FDA medical device recall by Cuattro LLC, initiated 2019-10-15, terminated 2021-04-27. It names one FDA 510(k) clearance: K161937. Product: CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0. 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: Cuattro LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-15
Terminated: 2021-04-27
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K161937 — CuattroDRCuattro, LLC·cleared 2016-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.