FDAClass IIAugust 10, 2016

Merge PACS software. The firm name on the label is recall

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and…

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

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

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: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.

Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and…
Recalling firm
Merge Healthcare, Inc.
Quantity
109 sites have the affected versions
Distribution
Worldwide Distribution -- USA, New Zealand, and United Kingdom.
Recall date
August 10, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls