FDAFDA · Food and drugs·Recall number Z-1091-2017
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Published February 1, 2017 · Recall initiated: March 28, 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
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.
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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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