Merge Eye Station Software Recalled for Potential Data Deletion
Merge Healthcare is recalling Merge Eye Station software versions 11.6.0 and prior due to a risk of accidental patient record deletion.
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, but the hazard is a software defect leading to data loss rather than a physical injury or death. Per the rubric, this falls under moderate risk as it involves a significant functional defect without reported physical harm.
Plain-English summary
Merge Healthcare, Inc. is recalling the Merge Eye Station software, formerly known as the DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager. The recall covers software versions 11.6.0 and prior, which were distributed by Ophthalmic Imaging Systems (OIS). A total of 1,597 units are affected, with 1,451 in the United States and 146 outside the U.S.
The recall was initiated because of an issue that allows for the potential accidental deletion of patient records by an Eye Station user. This is a software defect that compromises data integrity rather than posing a direct physical hazard to patients.
The affected software was distributed across 50 U.S. states and the District of Columbia, as well as 17 countries outside the United States. Users of the affected software versions should contact Merge Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
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)
- Merge Eye Station software versions: 11.6.0 and prior
Distribution
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