The Recall Desk
HighFDA (Devices)·Z-1613-2016·Announced 2016-05-18

Novarad NovaPACS Diagnostic Viewer Recalled for Incorrect SUV Calculations

Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.

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 medical device with a defect that produces incorrect diagnostic values, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Novarad Corporation is recalling NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. The recall involves 2,386 units that were distributed nationwide, as well as to 3 Canadian and 33 foreign consignees. The source text does not indicate distribution to VA, government, or military entities.

The recall is being conducted because the SUV values calculated by the PET/CT fusion tool in these software versions are incorrect. This defect affects the accuracy of the diagnostic data generated by the software.

The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Manufacturer
Novarad Corporation
Category
Medical Device — Software
Hazard
Affected units
2,386

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 (4)

  • Versions 8.3.7
  • 8.4.2
  • 8.4.3
  • and 8.4.4

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Novarad Corporation

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Same hazard · incorrect data

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