Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping
Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.
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 and involves a risk-of-harm product (medical imaging software) where incorrect image orientation could lead to diagnostic errors, but no injuries or illnesses have been reported.
Plain-English summary
Novarad Corporation is recalling NovaPACS Diagnostic Viewer software, specifically versions 7.4, 7.5, 7.6, and 8.0. This product is a picture archiving and communication system (PACS) used for diagnostic imaging. The recall involves 2,695 units distributed worldwide, including nationwide in the United States, with no distribution in Canada.
The recall was initiated due to a potential defect where images may be flipped while streaming. This issue could result in the incorrect display of image orientation markers. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users of the affected software versions should contact Novarad Corporation for further instructions on how to address the issue. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
- Manufacturer
- Novarad Corporation
- Category
- Medical Device — Software
- Affected units
- 2,695
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)
- All NovaPAC software versions 7.4
- 7.5
- 7.6
- and 8.0
Distribution
Distributed nationwide across the United States.
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