Merge Eye Station Import Utility Recalled for System Lockup Risk
Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient injury or delayed treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling the Merge Eye Station Import Utility (ESIU) software, versions 1.1.2 and 1.1.3. The recall is due to a defect where the system may lock up, which could result in potential patient injury or a delay in diagnosis or treatment.
The affected software was distributed nationwide in the United States to medical facilities, as well as to Canada. The source indicates that 78 sites potentially have the affected accessory. Government distribution was made, but there was no military distribution.
Medical facilities should contact Merge Healthcare for further instructions on how to address the software defect.
The recalled product
- Product
- Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 78
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)
- Versions 1.1.2 and 1.1.3
Distribution
Distributed nationwide across the United States.
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