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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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