FDA recall Z-1934-2020

Product

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

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.

Distribution

US: NJ, MI, SC, NC, MI, AR, OUS: None

Key facts

Status

Terminated

Initiation date

2019-10-15

Report date

2020-05-20

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Golden, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2020