510(k) K181830 ยท OWB Interventional Fluoroscopic X-Ray System
Azurion R2.0
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Aug 2, 2018 |
| Received | Jul 9, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M12. Model Numbers: 722063, 722221. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M12. Model Number: 722227. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M20. Model Numbers: 722228, 722281. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B12. Model Numbers: 722067, 722225. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B20. Model Numbers: 722068, 722226. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M12. Model Numbers: 722078, 722223. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. Open, Classified |
OWB | None listed |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion S. Model Number: 722285. Open, Classified |
OWB | None listed |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion under the following System Descriptions and corresponding model numbers:
1. Azurion 3 M12; Model Numbers: 722063, 722221.
2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 with the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 with the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 with the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 with the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 with the Roadmap Pro Software key Open, Classified |
OWB | None listed |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers.
1. Azurion 3 M12; Model Numbers: 722063, 722229 Open, Classified |
OWB | None listed |
| May 12, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222 Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M12
System Model Numbers: (1) 722063, (2) 722221, (3) 722229;
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M15
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B12
System Model Numbers:(1) 722067, (2) 722225, (3) 722235;
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B20
System Model Numbers: (1)722068, (2)722226, (3)722236;
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M12
System Model Numbers: (1)722078, (2)722223, (3)722233;
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M12
System Model Numbers: (1)722227, (2)722231;
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Feb 11, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M20
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X Open, Classified |
OWB | None listed |
| Jan 14, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models:
1. Azurion 3 M12. Model Numbers: 722063, 722221.
2. Azurion 3 Open, Classified |
OWB | None listed |
| Sep 3, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers:
1. Azurion 3 M12, Model Number 722063.
2. Azurion 3 M1 Open, Classified |
OWB | None listed |
| Jul 18, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20. Fluoroscopic X-Ray System. Open, Classified |
OWB | None listed |
| Jun 12, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion R1.x and R2.x systems;
Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 72 Open, Classified |
OWB | None listed |
| Sep 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.
Models/Model Number:
(1) Azurion 3M12: 722063, 722221;
(2) Azurion 3M15: 722064, 722222;
(3) Azurion SM12: 7 Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.
Affected PCs: FlexViewing PC
Azurion Model Name - Model Number:
Azur Open, Classified |
OWB | None listed |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. Azurion Open, Classified |
OWB | None listed |
| Feb 2, 2022 | Philips North America Llc Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, Open, Classified |
LLZ | None listed |
| Nov 12, 2021 | Philips North America Llc Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue
Model Numbers: 722221, 722228, 722225, 7220 Terminated |
OWB | None listed |
| Sep 24, 2021 | Philips North America Llc Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, Terminated |
JAA | None listed |
| Apr 29, 2020 | Philips North America, LLC Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system
Interventional fluoroscopic x-ray system
System code: 722079 Terminated |
OWB | None listed |
| Mar 5, 2020 | Philips North America, LLC Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079
Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vasc Terminated |
JAA | None listed |
| Feb 10, 2020 | Philips North America, LLC VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion Terminated |
OWB | None listed |
| Mar 12, 2019 | Philips North America, LLC Azurion FlexArm, 722079 Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.