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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 32 Results
510(K) Number: K172822
 
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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
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and... 2 02/10/2020 Philips North America, LLC
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as fo... 2 08/06/2019 Philips North America, LLC
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 2 07/30/2019 Philips Medical Systems Nederlands
Azurion systems with software release R1.x 2 05/03/2022 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 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - ... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - A... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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