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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
510(K) Number: K181830
 
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Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Az... 2 04/06/2022 Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration st... 2 01/10/2022 Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 7220... 2 11/09/2021 Philips North America Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the ... 2 04/29/2020 Philips North America, LLC
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, inter... 2 04/24/2020 Philips North America, LLC
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and... 2 02/10/2020 Philips North America, LLC
Azurion FlexArm, 722079 2 04/11/2019 Philips North America, LLC
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Softw... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Nu... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: ... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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