Recall Z-1934-2020 ยท KPR System, X-Ray, Stationary
Cuattro LLC
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
| Date | Oct 15, 2019 |
| Status | Terminated |
| 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. |
| 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 | 9 units |
| Distribution | US: NJ, MI, SC, NC, MI, AR, OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161937 | CuattroDR Cuattro, LLC, Oct 6, 2016 |