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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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Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 2 07/30/2019 Philips Medical Systems Nederlands
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as fo... 2 08/06/2019 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 Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Az... 2 04/06/2022 Philips North America Llc
Azurion systems with software release R1.x 2 05/03/2022 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 2 09/07/2023 Philips Medical Systems Nederland B.V.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 2 02/04/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 2 02/04/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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