FDAFDA · Food and drugs·Recall number 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.

Published June 5, 2024 · Recall initiated: May 2, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential for pressure wave data synchronization from two devices may not be correct.

What to do

Voluntary: Firm initiated

Recall details

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distributor: 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.
Lot: 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
Risk classification: Class II
Area (FDA): device
Country: Netherlands

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