FDAFDA · Alimentos y medicamentos·N.º oficial Z-1969-2026
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Publicado el 6 de mayo de 2026 · Inicio del retiro: 14 de abril de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips North America
- Distribuidor
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
- Lote
- 1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052, (01)00884838104402(21)42030, (01)00884838104402(21)42151, (01)00884838104402(21)71279, (01)00884838104402(21)71565, (01)00884838104402(21)42104, (01)00884838104402(21)42163, (01)00884838104402(21)42376, (01)00884838104402(21)45179, (01)00884838104402(21)45236, (01)00884838104402(21)45263, (01)00884838104402(21)71532, (01)00884838104402(21)85394, (01)00884838104402(21)85643, (01)00884838104402(21)85644. Serial Numbers: 45052, 42030, 42151, 71279, 71565, 42104, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, 85644.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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