Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Reported: January 6, 2016 Initiated: October 26, 2015 #Z-0554-2016
Product Description
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Reason for Recall
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 2
- Distribution
- Distributed in the states of IL, NC, and VT.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.. Recalled by Merge Healthcare, Inc.. Units affected: 2.
Why was this product recalled? ▼
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2016. Severity: Moderate. Recall number: Z-0554-2016.
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