Cuattro LLC CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Brand
Cuattro LLC
Lot Codes / Batch Numbers
Product Version: 4.4.128
Products Sold
Product Version: 4.4.128
Cuattro LLC is recalling CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, MI, NJ, NC, SC
Page updated: Jan 10, 2026