FDAFDA · Alimentos y medicamentos·N.º oficial Z-1246-2017
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Publicado el 1 de marzo de 2017 · Inicio del retiro: 28 de marzo 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
Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
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 nationwide to medical facilities. There was also government and foreign distribution, including Canada.
- Lote
- Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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