Browse recalls

Country of alert: Netherlands

93 indexed recall(s) · All filters →

• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 5 M12. Model Number: 722227.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 5 M20. Model Numbers: 722228, 722281.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion S. Model Number: 722285.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 7 B20. Model Numbers: 722068, 722226.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 7 M12. Model Numbers: 722078, 722223.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 3 M12. Model Numbers: 722063, 722221.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 7 B12. Model Numbers: 722067, 722225.
• 2026-10-06 · US FDA — Medical DevicesClass II
  Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
• 2026-07-16 · US FDA — Medical DevicesClass II
  Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versi
• 2026-07-16 · US FDA — Medical DevicesClass II
  Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,
• 2026-05-07 · US FDA — Medical DevicesClass II
  3mensio Workstation (Vascular Fenestrated) software
• 2026-04-30 · US FDA — Medical DevicesClass II
  Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),
• 2026-04-30 · US FDA — Medical DevicesClass II
  Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T
• 2026-04-28 · US FDA — Medical DevicesClass II
  Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (
• 2026-04-28 · US FDA — Medical DevicesClass II
  Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ
• 2026-04-28 · US FDA — Medical DevicesClass II
  Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X
• 2026-03-19 · US FDA — Medical DevicesClass II
  Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended
• 2026-02-06 · US FDA — Medical DevicesClass II
  BD Kiestra" ReadA; Catalog No.: 446948.
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD10F; Model Number: 722002;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD10/10; Model Number: 722027;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD20; Model Number: 722028;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Product Name: Allura Xper FD10C; Model number: 722001;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD10; Model Number: 722003;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD10/10; Model Number: 722011;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD20/20; Model Number: 722038;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD10/10; Model Number: 722005;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD20; Model Number: 722012;
• 2025-12-15 · US FDA — Medical DevicesClass II
  Allura Xper FD20/10; Model Number: 722029;
• 2025-12-12 · US FDA — Medical DevicesClass II
  Philips Azurion system; Software Version Number: R3.1;
• 2025-12-12 · US FDA — Medical DevicesClass II
  Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres
• 2025-12-08 · US FDA — Medical DevicesClass II
  Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419
• 2025-09-03 · US FDA — Medical DevicesClass II
  Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979,
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13
• 2025-09-03 · US FDA — Medical DevicesClass II
  Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1
• 2025-03-27 · US FDA — Medical DevicesClass II
  Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 1.5T Master/Nova, Model Number: 781106;
• 2025-03-24 · US FDA — Medical DevicesClass II
  SmartPath to dStream for 3.0T, Model Number: 782145;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
• 2025-03-24 · US FDA — Medical DevicesClass II
  SmartPath to dStream for 1.5T, Model Number: 782146;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 1.0T Omni/Stellar, Model Number: 781102;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Enterprise 1.5T, Model Number: 781145;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 1.5T Omni/Stellar, Model Number: 781104;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 0.5T Standard, Model Number: 781101;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 3.0T Quasar Dual, Model Number: 781150;
• 2025-03-24 · US FDA — Medical DevicesClass II
  Intera 1.5T Power/Pulsar, Model Number: 781105;
• 2025-01-13 · US FDA — Medical DevicesClass II
  Azurion 3 M12 System Code: (1) 722063 (2) 722221
• 2025-01-13 · US FDA — Medical DevicesClass II
  Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
• 2025-01-13 · US FDA — Medical DevicesClass II
  Allura CV20 System Code: 722031
• 2025-01-13 · US FDA — Medical DevicesClass II
  Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXperFD20/10 System Code: (1) 722029
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
• 2025-01-13 · US FDA — Medical DevicesClass II
  Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXperFD20/15 System Code: (1) 722058
• 2025-01-13 · US FDA — Medical DevicesClass II
  Azurion 5 M12 System Code: (1) 722227 (2) 722231
• 2025-01-13 · US FDA — Medical DevicesClass II
  AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
• 2024-11-11 · US FDA — Medical DevicesClass II
  Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2.
• 2024-08-06 · US FDA — Medical DevicesClass II
  Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number
• 2024-02-06 · US FDA — Medical DevicesClass II
  Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg
• 2024-02-06 · US FDA — Medical DevicesClass II
  Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur
• 2024-01-02 · US FDA — Medical DevicesClass II
  Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected
• 2024-01-02 · US FDA — Medical DevicesClass II
  Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
• 2023-12-07 · US FDA — Medical DevicesClass II
  Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro