CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
CuattroDR System recalled
Cuattro is recalling CuattroDR System, distributed in Arkansas, Michigan, North Carolina, New Jersey, South Carolina. The recall was initiated on 15 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1934-2020
- FDA event ID
- 85446
- Recalling firm
- Cuattro, Golden, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2019
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 15 Oct 2019 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +206 days |
| 20 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Where it was distributed
US: NJ, MI, SC, NC, MI, AR, OUS: None
Questions about this recall
Is CuattroDR System recalled?
Yes. Cuattro recalled CuattroDR System on 15 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-1934-2020.
Why was it 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.
Which lots are affected?
Product Version: 4.4.128
Where was it sold?
US: NJ, MI, SC, NC, MI, AR, OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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