The Recall Desk
ModerateFDA (Devices)·Z-0555-2016·Announced 2016-01-06

Merge Healthcare Recalls Unvalidated Cardio and HEMO Software Versions

Merge Healthcare is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software distributed to three customers before complete in-house validation.

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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, stemming from the lack of complete in-house validation rather than a confirmed defect causing harm.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software. The recall was initiated because the software was distributed to three customers before the product was completely validated in-house.

The affected software is intended to allow users to review diagnostic and non-diagnostic quality images. The recall covers one unit of the product, which was distributed in the states of Illinois, North Carolina, and Vermont.

No specific instructions for consumers are provided in the source text, but the recall is limited to the three customers who received the software prior to full validation.

The recalled product

Product
Merge Cardio with software version 10.1 LA.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
1

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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