Agency classClass IIOur severity:High FDA (Devices)·Z-0289-2021·Announced 2020-11-04

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.

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-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
Hazard: software-defect
incorrect-data
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

Distributed in 15 states:

Same manufacturer · Merge Healthcare, Inc.

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