Merge Eye Care Systems Software Recall Due to Image Acquisition Failure
Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is a functional software failure that prevents image acquisition, which is a significant operational issue but does not involve a direct physical injury or death risk to patients.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Eye Care Systems, which includes the Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). The recall affects all versions of these software components.
The recall is being issued because the system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. This functional failure prevents the software from performing its intended purpose of handling medical images.
Distribution was made to medical facilities nationwide, as well as to government facilities. The software was also distributed to Canada and other countries, but there was no military distribution. Approximately 1,627 sites potentially have the affected software. Users should contact Merge Healthcare for instructions on resolving the software incompatibility.
The recalled product
- Product
- Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- 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 (3)
- All versions of Eye Care PACS
- Eye Station
- and ESIU.
Distribution
Distributed nationwide across the United States.
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