FDAFDA · Alimentos y medicamentos·N.º oficial Z-1926-2024
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Publicado el 5 de junio de 2024 · Inicio del retiro: 2 de mayo de 2024
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
Potential for pressure wave data synchronization from two devices may not be correct.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distribuidor
- Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.
- Lote
- Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, (01)00884838101180(21)2111600887, (01)00884838101180(21)629, (01)00884838101180(21)2111600641, (01)00884838101180(21)2111601079, (01)00884838101180(21)2111601443, (01)00884838101180(21)2111601444, (01)00884838101180(21)1104, (01)00884838101180(21)1133, (01)00884838101180(21)812, (01)00884838101180(21)2111601067, (01)00884838101180(21)571, (01)00884838101180(21)2111600465, (01)00884838101180(21)2111600628, (01)00884838101180(21)2111600809, (01)00884838101180(21)1195, (01)00884838101180(21)2111601172, (01)00884838101180(21)2111601176, (01)00884838101180(21)168, (01)00884838101180(21)2111600797, (01)00884838101180(21)2111600664, (01)00884838101180(21)195, (01)00884838101180(21)196, (01)00884838101180(21)780, (01)00884838101180(21)781, (01)00884838101180(21)69, (01)00884838101180(21)2111600764, (01)00884838101180(21)2111601312, (01)00884838101180(21)2111600814, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
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