The Recall Desk
HighFDA (Devices)·Z-1934-2020·Announced 2020-05-20

CuattroDR System Software Recalled for Potential Image Misattribution

Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.

Plain-English summary

Cuattro LLC is recalling 9 units of CuattroDR System Software (REF: SWR-00069-MD, UDI: B269SWR00069MD0, Product Version: 4.4.128). The recall is due to a potential software defect where an image from a previous patient study may appear in a later patient study.

This issue may result in the misdiagnosis of the correct patient. The affected units were distributed in the United States to New Jersey, Michigan, South Carolina, and North Carolina. No units were distributed outside the United States.

The source text does not specify specific actions for consumers or healthcare providers, such as contacting the manufacturer or halting use. Users should refer to official FDA channels or the recalling firm for specific instructions on how to proceed.

The recalled product

Product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Manufacturer
Cuattro LLC
Category
Medical Device — Software
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Version: 4.4.128

Distribution

Distributed in 5 states:

Related recalls

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