FDAFDA · Alimentos y medicamentos·N.º oficial Z-1681-2017
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Publicado el 5 de abril de 2017 · Inicio del retiro: 4 de abril de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Merge Healthcare, Inc.
- Distribuidor
- 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.
- Lote
- All versions of Eye Care PACS, Eye Station, and ESIU.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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