Z-1934-2020Class II

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

Name: Z-1934-2020 CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Creator: Cuattro LLC
Published: 2019-10-15
License: https://open.fda.gov/license/

Cuattro Imaging, LLC / initiated 2019-10-15 / Terminated / root cause: design

FDA source

Cuattro LLC began a recall of CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 on 2019-10-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1934-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-15
Posted: 2020-05-08
Terminated: 2021-04-27
Recalling firm: Cuattro Imaging, LLC
Product: CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: design
FDA root cause: Device Design
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
Quantity in commerce: 9 units
Distribution: US: NJ, MI, SC, NC, MI, AR, OUS: None
Product codes and lots: Product Version: 4.4.128

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1934-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1934-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code KPR

K161937Class IICuattroDRCuattro, LLC / cleared 2016-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)