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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The 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 FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: (01)00884838116757(21)5Model (01)00884838116771(21)686Model (01)00884838116771(21)521Model (01)00884838116771(21)812Model (01)00884838116771(21)163Model (01)00884838116801(21)127Model (01)00884838116757(21)34Model (01)00884838116733(21)61Model (01)00884838116764(21)226Model (01)00884838116771(21)327Model (01)00884838116764(21)277Model (01)00884838116771(21)780Model (01)00884838116771(21)429Model (01)00884838116764(21)276Model (01)00884838116788(21)87Model (01)00884838116801(21)37Model (01)00884838116771(21)362Model (01)00884838116771(21)502Model (01)00884838116740(21)77Model (01)00884838116757(21)106Model (01)00884838116771(21)222Model (01)00884838116771(21)545Model (01)00884838116801(21)159Model (01)00884838116801(21)345Model (01)00884838116771(21)987UPC 00884838116757UPC 00884838116771UPC 00884838116801UPC 00884838116733UPC 00884838116764UPC 00884838116788UPC 00884838116740Would you have heard about this one?
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