FDAClass IIJuly 20, 2016

NovaPACS  versions 7.4 recall

NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

Why was NovaPACS  versions 7.4 recalled?

Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0

Product
NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Recalling firm
Novarad Corporation
Quantity
2695
Distribution
Worldwide distribution including US nationwide. No Canadian distribution.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls