Merge Eye Station Import Utility Recalled for Image Import Errors
Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.
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: This is an FDA Class II recall involving a software defect that causes data integrity issues (images imported as 'unknown') but does not involve a direct physical hazard or reported injuries, fitting the criteria for a moderate severity software recall.
Plain-English summary
Merge Healthcare, Inc. is recalling the Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The recall is due to a software issue where eye station images were not importing properly and were imported under "unknown" when validating patients using only a Medical Record Number (MRN).
The affected software versions include Merge ESIU versions 1.0, 1.1.1, 1.1.2, and 1.1.3; all versions of Merge Eye Station; and Merge Eye Care PACS versions 4.1, 4.2, 4.3, 5.0, and 5.1. The product was distributed nationwide to medical facilities, as well as to government and foreign locations including Canada. Approximately 1,627 sites potentially have the affected versions.
Medical facilities should contact Merge Healthcare for further instructions on how to resolve the issue. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
- 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 (10)
- Merge ESIU: Versions 1.0
- 1.1.1
- 1.1.2
- and 1.1.3
- Merge Eye Station: All versions
- Merge Eye Care PACS: Versions 4.1
- 4.2
- 4.3
- 5.0
- and 5.1
Distribution
Distributed nationwide across the United States.
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