FDAFDA · Food and drugs·Recall number Z-1778-2017
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
Published April 19, 2017 · Recall initiated: April 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
- Lot
- Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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