FDAClass IINovember 23, 2016

Merge LIS software recall

Merge LIS software.

Why was Merge LIS software recalled?

There is a potential for duplicate container numbers to be created for patients.

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: 4.0.1 and earlier.

Product
Merge LIS software.
Recalling firm
Merge Healthcare, Inc.
Quantity
413 sites potentially have the affected software
Distribution
Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls