The Recall Desk
HighFDA (Devices)·Z-2956-2020·Announced 2020-09-23

Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

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 is classified as FDA Class II. The hazard involves a software defect that could lead to inaccurate image display, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Novarad Corporation is recalling 197 units of NovaPACS Diagnostic Viewer software. The recall involves specific versions of the software, including 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8. The software is a picture archiving and communication system used to retrieve, distribute, and display images from various medical modalities such as CT, MR, US, CR/DX, NM, PT, and XA.

The recall was initiated after the firm received a report of an atypical dataset being generated. The issue occurs when using the cross-localization feature with images from modalities that generate asymmetrical images. In these cases, the cross-localization reference line may be inaccurately placed on any of the corresponding open images.

The affected software was distributed worldwide, including nationwide in the United States and in Canada, Colombia, Dominican Republic, Indonesia, Jordan, Mexico, Peru, Philippines, and the United Kingdom. Users of the affected software versions should contact Novarad Corporation for further instructions on resolving the issue.

The recalled product

Product
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
Manufacturer
Novarad Corporation
Category
Medical Device — Software
Hazard
Affected units
197

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 (8)

  • NovaPACS versions 8.6.8
  • 8.6.9
  • 8.6.11
  • 8.6.12
  • 8.6.14
  • 8.7.4
  • 8.7.6
  • and 8.7.8

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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