FDAClass IIJune 21, 2017

Merge PACS software. Merge PACS recall

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of…

Why was Merge PACS software. Merge PACS recalled?

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

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 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2

Product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of…
Recalling firm
Merge Healthcare, Inc.
Quantity
47 sites have the potentially affected versions
Distribution
Nationwide Distribution
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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