FDAClass IIJune 28, 2017

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

Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

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

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

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, 6.6.2, 6.6.2.1, and 6.6.2.2

Product
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalling firm
Merge Healthcare, Inc.
Quantity
160 sites potentially have the affected versions
Distribution
USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
Recall date
June 28, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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