Agency classClass IIOur severity:High FDA (Devices)·Z-1091-2017·Announced 2017-02-01

Merge Hemo software recall due to potential connection issues

Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

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 the hazard involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of the Merge Hemo software. This software is used to monitor, measure, and record physiologic data from human patients undergoing cardiac catheterization procedures. The affected versions include 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3.

The recall is due to a potential connection issue where the Hemo Monitor does not communicate with the Client PC when powering up the Merge Hemo Record Station. This failure to communicate could impact the monitoring and recording of patient data during procedures.

The product was distributed nationwide, and 242 sites potentially have the affected versions. The U.S. Food and Drug Administration has classified this as a Class II recall. Users of the affected software should contact Merge Healthcare, Inc. for further instructions on how to address the issue.

The recalled product

Product: Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: connection-failure
Affected units: 242

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 (18)

Versions 6.10
6.10.1
6.10.2
6.10.3
7.10
7.20
7.20.1
8.10.0
8.20
9.10.0
9.20
9.20.2
9.20.3
9.30
9.40
9.40.1
9.40.2
and 9.40.3

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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