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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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