Merge Healthcare Recalls Merge LIS Software Due to Medication Display Error
Merge Healthcare is recalling 47 units of Merge LIS software because a defect causes unrelated medications to appear on patient reports.
What this means for you
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-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling 47 units of Merge LIS software. The recall affects specific versions of the software, including 4.0.1, 4.1, and various 4.1.x patches. The product was distributed domestically in Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, and Texas.
The recall is due to a software defect that results in medications not associated with the patient appearing on their reports. Specifically, the defect causes medications that the patient is not currently taking to be displayed on the report.
Healthcare facilities using the affected software should contact Merge Healthcare for instructions on how to resolve the issue. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Merge LIS
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 47
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 (9)
- Merge LIS versions 4.0.1
- 4.1
- 4.1.1
- 4.1.2
- 4.1.3
- 4.1.4
- 4.1.5
- 4.1.5 Patch 1
- and 4.1.5 Patch 2
Distribution
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