FDA Device recall Z-1934-2020
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 by Cuattro, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1934-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-15 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cuattro |
| Distribution | AR, MI, NC, NJ, SC |
Product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
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.
Identifiers
| code_info | Product Version: 4.4.128 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1934-2020%22
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