FDAFDA · Food and drugs·Recall number Z-1681-2017
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Published April 5, 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
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
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 made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
- Lot
- All versions of Eye Care PACS, Eye Station, and ESIU.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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