Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reported: April 19, 2017 Initiated: April 4, 2016 #Z-1778-2017
Product Description
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason for Recall
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 24 sites potentially have the affected versions
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Recalled by Merge Healthcare, Inc.. Units affected: 24 sites potentially have the affected versions.
Why was this product recalled? ▼
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1778-2017.
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