FDAClass IIJuly 20, 2016

Merge OfficePACS software. The firm name on the label recall

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

Why was Merge OfficePACS software. The firm name on the label recalled?

Potential data loss occurs as a result of product archiving not working properly.

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?

Version 3.4

Product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Recalling firm
Merge Healthcare, Inc.
Quantity
49 sites have the affected software
Distribution
Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls