Home / Recalls / Medical Devices
Cuattro LLC recalls CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Recalled May 20, 2020 · FDA recall Z-1934-2020 · Cuattro
Hazard
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. · FDA Class II
Units
9 units
Sold at
US: NJ, MI, SC, NC, MI, AR, OUS: None
Description
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.
Product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Manufacturer(s)
Cuattro LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →