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Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Class II
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for recall
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Affected products (lot / model / serial)
UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, (01)00884838116764(21)99, (01)00884838116740(21)37, (01)00884838116801(21)421, (01)00884838116771(21)718, (01)00884838116801(21)212, (01)00884838116764(21)122, (01)00884838116801(21)17, (01)00884838116764(21)344, (01)00884838116771(21)287, (01)00884838116757(21)140, (01)00884838116764(21)169, (01)00884838116771(21)822, (01)00884838116801(21)25, (01)00884838116801(21)180, (01)00884838116771(21)88, (01)00884838116788(21)127, (01)00884838116771(21)363, (01)00884838116801(21)227, (01)00884838116771(21)716, (01)00884838116771(21)185, (01)00884838116771(21)1145, (01)00884838116771(21)426, (01)00884838116801(21)235, (01)00884838116771(21)292, (01)00884838116771(21)252, (01)00884838116801(21)131, (01)00884838116771(21)332, (01)00884838116771(21)993, (01)00884838116771(21)97, (01)00884838116771(21)359, (01)00884838116771(21)1088, (01)00884838116764(21)350, (01)00884838116771(21)893, (01)00884838116801(21)288, (01)00884838116771(21)346, (01)00884838116771(21)695, (01)00884838116771(21)383, (01)00884838116771(21)300, (01)00884838116771(21)804, (01)00884838116801(21)504, (01)00884838116771(21)186, (01)00884838116764(21)267, (01)00884838116771(21)1354, (01)00884838116771(21)1246, (01)00884838116771(21)99, (01)00884838116771(21)413, (01)00884838116801(21)231, (01)00884838116771(21)547, (01)00884838116771(21)449, (01)00884838116757(21)99, (01)00884838116801(21)203, (01)00884838116771(21)75, (01)00884838116771(21)813, (01)00884838116801(21)138, (01)00884838116771(21)447, (01)00884838116771(21)915, (01)00884838116771(21)511, (01)00884838116788(21)117, (01)00884838116801(21)426, (01)00884838116801(21)20, (01)00884838116771(21)484, (01)00884838116801(21)249, (01)00884838116757(21)392, (01)00884838116771(21)626, (01)00884838116771(21)215, (01)00884838116764(21)96, (01)00884838116771(21)704, (01)00884838116764(21)108, (01)00884838116771(21)248, (01)00884838116771(21)594, (01)00884838116771(21)87, (01)00884838116771(21)333, (01)00884838116788(21)76, (01)00884838116771(21)1226, (01)00884838116771(21)927, (01)00884838116771(21)1037, (01)00884838116771(21)1140, (01)00884838116771(21)286, (01)00884838116771(21)173, (01)00884838116771(21)395, (01)00884838116801(21)200, (01)00884838116757(21)12, (01)00884838116771(21)68, (01)00884838116801(21)468, (01)00884838116771(21)656, (01)00884838116801(21)208, (01)00884838116771(21)459, (01)00884838116771(21)848, (01)00884838116757(21)138, (01)00884838116801(21)42, (01)00884838116771(21)71, (01)00884838116771(21)465, (01)00884838116801(21)205, (01)00884838116771(21)855, (01)00884838116801(21)183, (01)00884838116757(21)101, (01)00884838116771(21)377, (01)00884838116771(21)854, (01)00884838116771(21)517, (01)00884838116771(21)330, (01)00884838116801(21)363, (01)00884838116771(21)370, (01)00884838116757(21)91, (01)00884838116771(21)660, (01)00884838116771(21)501, (01)00884838116771(21)535, (01)00884838116771(21)463, (01)00884838116771(21)320, (01)00884838116771(21)1248, (01)00884838116801(21)81, (01)00884838116771(21)817, (01)00884838116771(21)516, (01)00884838116771
Units affected
2016 units
Distribution pattern
Worldwide distribution.
Firm location
Best, Netherlands
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2932-2026
Recall initiated
July 16, 2026
FDA classification date
August 10, 2026
FDA report date
August 19, 2026
FDA event ID
99423
Last updated on HTM Vibe
August 26, 2026
View on openFDA