Devices

Device Recall Merge Hemo software

Model / Serial
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
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Manufacturer
Merge Healthcare, Inc.
1 Event
- Recall of Device Recall Merge Hemo software

Manufacturer

Merge Healthcare, Inc.

Manufacturer Address
Merge Healthcare, Inc., 900 Walnut Ridge Dr, Hartland WI 53029-8347
Manufacturer Parent Company (2017)
International Business Machines Corp.
Source
USFDA

One device with a similar name

Learn more about the data here

Device Recall Merge HEMO software

Model / Serial
Software versions 8.10, 9.10, 9.20.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Product Description
Merge HEMO software.
Manufacturer
Merge Healthcare, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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