Reported May 20, 2020 · Terminated
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Cuattro LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cuattro LLC · 150 Capital Dr Ste 280 · Golden, CO · 80401
Is this the product you have?
- CuattroDR System Software
- REFSWR-00069-MD
- UDIB269SWR00069MD0
- Lot codes and dates
- Product Version4.4.128
- Amount recalled
- 9 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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