FDAClass IINovember 23, 2016

iConnect Access software. The firm name on the label is recall: Software Issue

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

Why was iConnect Access software. The firm name on the label is recalled?

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

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?

Versions 3.0.1, 3.1, and 3.2

Product
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalling firm
Merge Healthcare, Inc.
Quantity
60 sites potentially have the affected versions
Distribution
Distribution was made to medical facilities nationwide. Foreign distribution was also made.
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls