United StatesPhilips Azurion interventional fluoroscopic x‑ray systems, model numbers 722229–722236 with software versions R3.0 or R3.1, are affected. They were recalled because of two software-related issues: potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment, and potential loss of geometry movements that may lead to delay of therapy and procedural complications.
What's being recalled
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
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
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…
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada