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Terminated

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

FDA Recall Z-1934-2020 · Posted None

Recalling FirmCuattro LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2019-10-15
Date Terminated2021-04-27
Product Quantity9 units

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.

Firm Action

On October 15, 2019, The firm contacted all affected consignees via phone call. In addition to informing consignees about the recall. The firm provided the following information to consignees: . To prevent a reoccurrence of this problem Cuattro has updated the settings file in the program data folder on your acquisition workstation. This update to the file will prevent any backup images from being downloaded to the acquisition workstation. This was completed for your system on September 6, 2019, service ticket number 70002871

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161937CuattroDRCuattro, LLC · 2016-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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