The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2659-2016·Announced 2016-08-31

Novarad NovaPACS Software Recalled for Prematurely Released Pop-up Screen

Novarad Corporation is recalling NovaPACS software versions 8.4.7, 8.5.3, and 8.5.6 due to a prematurely released pop-up screen.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is described as a voluntary field action for a software issue (prematurely released pop-up screen) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Novarad Corporation is conducting a voluntary field action for NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. The recall is due to a "pop-up screen" that was prematurely released. NovaPACS is a picture archiving and communication system (PACS) software used to retrieve, archive, distribute, and display medical images and data.

Approximately 90 units of the affected software were distributed worldwide, including in the United States, Canada, and other foreign locations. The software is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses, for the viewing, archiving, analysis, and processing of digital medical images.

The source text does not specify specific instructions for consumers or healthcare providers regarding the next steps for this field action.

The recalled product

Product
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data…
Manufacturer
Novarad Corporation
Category
Medical Device — Software
Hazard
Affected units
90

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 (3)

  • Versions 8.4.7
  • 8.5.3
  • and 8.5.6

Distribution

Distributed nationwide across the United States.

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