FDAFDA · Food and drugs·Recall number Z-1415-2017
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
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
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
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
- US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
- Lot
- Version 9.0.9 and earlier using EchoIMS.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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