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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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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
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label des... 2 01/14/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the fo... 2 09/03/2025 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.
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 lnterventional Fluoroscopic X-ray System, with software version 1.2 2 07/30/2019 Philips Medical Systems Nederlands
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 7... 2 06/12/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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