Philips Azurion X-ray systems recalled for software image and movement issues
Philips is recalling certain Azurion interventional fluoroscopic X-ray systems, model numbers 722229 through 722236, running software versions R3.0 and R3.1. The software can degrade image quality, and it can also cause loss of geometry movements, which may delay treatment or complicate procedures. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Check with your facility or Philips for the software update or corrective instructions.
- Contact Philips Medical Systems with any questions about your system.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 2016 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-2932-2026
In the FDA's words
- Description
- 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 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 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(21)616, (01)00884838116764(21)271, (01)00884838116757(21)127, (01)00884838116771(21)475, (01)00884838116757(21)2, (01)00884838116771(21)270, (01)00884838116757(21)96, (01)00884838116757(21)316, (01)00884838116771(21)583, (01)00884838116771(21)887, (01)00884838116771(21)549, (01)00884838116801(21)148, (01)00884838116801(21)133, (01)00884838116764(21)322, (01)00884838116757(21)124, (01)00884838116757(21)317, (01)00884838116771(21)762, (01)00884838116771(21)617, (01)00884838116771(21)703, (01)00884838116771(21)178, (01)00884838116757(2
- Hazard
- 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
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