FDAFDA · Alimentos y medicamentos·N.º oficial Z-2566-2018
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Publicado el 8 de agosto de 2018 · Inicio del retiro: 7 de agosto de 2017
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 software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Merge Healthcare, Inc.
- Distribuidor
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- Lote
- Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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