Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reported: February 1, 2017 Initiated: March 28, 2016 #Z-1091-2017
Product Description
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason for Recall
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 242 sites potentially have the affected versions
- Distribution
- Nationwide Distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Recalled by Merge Healthcare, Inc.. Units affected: 242 sites potentially have the affected versions.
Why was this product recalled? ▼
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1091-2017.
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