The Recall Desk
ModerateFDA (Devices)·Z-1828-2017·Announced 2017-04-26

Merge Healthcare Recalls Eye Station and Eye Care PACS Software

Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential loss of medical data (images) due to software interaction, which is a significant operational risk but does not involve direct physical injury or death, fitting the Moderate category for non-physical defects.

Plain-English summary

Merge Healthcare, Inc. is recalling the Merge Eye Station and Merge Eye Care PACS software. The recall is due to a defect where an antivirus program scan may identify a newly captured image as an unwanted file and delete it permanently.

The affected software versions were distributed nationwide to medical facilities, as well as to Canada, other foreign countries, and government entities. Approximately 1,627 sites potentially have the affected versions installed.

Healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue and prevent the loss of patient images.

The recalled product

Product
Merge Eye Station and Merge Eye Care PACS.
Affected units
1,627

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All versions

Distribution

Distributed nationwide across the United States.