Device product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Z-1934-2020
Product summary
- Firm
- Cuattro LLC
- Event
- Event 85446
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1934-2020
Official wording
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.
Code information: Product Version: 4.4.128
Distribution pattern: US: NJ, MI, SC, NC, MI, AR, OUS: None
Derived failure modes
-
Unknown
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.