FDAClass IIJune 28, 2017

Merge OrthoPACS software recall

Merge OrthoPACS software.

Why was Merge OrthoPACS software recalled?

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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 6.6, 6.6.1, and 6.6.2

Product
Merge OrthoPACS software.
Recalling firm
Merge Healthcare, Inc.
Quantity
98 sites potentially have the affected versions
Distribution
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Recall date
June 28, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls