FDAClass IIAugust 2, 2023

vRad PACS with Mammography recall

vRad PACS with Mammography

Why was vRad PACS with Mammography recalled?

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

(01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1

Product
vRad PACS with Mammography
Recalling firm
Virtual Radiologic Corp.
Quantity
8 units
Distribution
US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
Recall date
August 2, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls