CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Reported: May 20, 2020 Initiated: October 15, 2019 #Z-1934-2020
Product Description
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.
Details
- Recalling Firm
- Cuattro LLC
- Units Affected
- 9 units
- Distribution
- US: NJ, MI, SC, NC, MI, AR, OUS: None
- Location
- Golden, CO
Frequently Asked Questions
What product was recalled? ▼
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0. Recalled by Cuattro LLC. Units affected: 9 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1934-2020.
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