FDAFDA · Food and drugs·Recall number Z-1486-2017
Merge Cardio software.
Published March 29, 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
Cardio study list does not show STAT studies without refreshing.
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
- Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.
- Lot
- Versions 9.0; 9.0.1; 9.0.2; 9.0.3; 9.0.4; 9.0.5; 9.0.6; 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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