Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best
Is this the product you have?
- Philips Azurion
- Model Numbers
722229722230722231722232722233722234722235and 722236
- with Software Version NumbersR3.0 and R3.1; Interventional fluoroscopic x-ray system
- Lot codes and dates
- UDI
1,903 of 1,903 codes
(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
- UDI
- Amount recalled
- 2016 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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