FDAClass IIApril 26, 2017

Merge Eye Station and Merge Eye Care PACS recall

Merge Eye Station and Merge Eye Care PACS.

Why was Merge Eye Station and Merge Eye Care PACS recalled?

During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

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?

All versions

Product
Merge Eye Station and Merge Eye Care PACS.
Recalling firm
Merge Healthcare, Inc.
Quantity
1,627 sites potentially have the affected versions
Distribution
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls