510(k) K200917 ยท OWB Interventional Fluoroscopic X-Ray System
Azurion R2.1
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, May 1, 2020 |
| Received | Apr 6, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200917
| 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 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar Open, Classified |
OWB | None listed |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system 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 16, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion system; Software Version Number: R3.1; Open, Classified |
OWB | None listed |
| Jan 14, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:
1. Azurion 3 M12. Model Number: 722229.
2. Azurion 3 M15. Model Number: 722230.
3. Azurion 5 M12. 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 |
| Dec 9, 2025 | Philips North America Azurion R3.0.
Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM Open, Classified |
JAA | None listed |
| Nov 26, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M20 systems with FlexArm ceiling-mounted system.
Model Number: 722234; 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 |
| 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 |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M12
System Code:
(1) 722063
(2) 722221 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M15
System Code:
(1) 722064
(2) 722222
(3) 722280 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M12
System Code:
(1) 722227
(2) 722231 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M20
System Code:
(1) 722228
(2) 722232
(3) 722281 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B12
System Code:
(1) 722067
(2) 722225
(3) 722235 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B20
System Code:
(1) 722068
(2) 722226
(3) 722236 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M12
System Code:
(1) 722078
(2) 722223
(3) 722233 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20
System code:
(1) 722224
(2) 722079
(3) 722234
(4) 722282
System Code:
(1) 722078
(2) 722223
(3) 722233 Open, Classified |
OWB | None listed |
| Sep 30, 2024 | Philips North America Azurion IGTS Fixed Systems Open, Classified |
OWB | None listed |
| Sep 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion Open, Classified |
OWB | None listed |
| Sep 4, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224 Open, Classified |
OWB | None listed |
| Aug 8, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number:
R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery proce Open, Classified |
OWB | None listed |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722221
(2) 722222
(3) 722280 Open, Classified |
OWB | None listed |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722227
(2) 722228 Open, Classified |
OWB | None listed |
| Feb 22, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722223,
(2) 722224,
(3) 722225,
(4) 722226 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: XRay PC, Suite PC, and FlexViewing PC
Azurion Model Nam 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 |
| Jan 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Open, Classified |
OWB | None listed |
| Jan 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Open, Classified |
OWB | None listed |
| Jan 26, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion system, Interventional fluoroscopic x-ray system.
System Product Name - Model Numbers
Azurion 3M12 -722063, 722221;
Azurion 3M15 - 722064, 722222;
Azurion 5M12 - 722227;
Azurion 5M2 Open, Classified |
OWB | None listed |
| Dec 15, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura systems with monoplane fixed ceiling mounts:
722001 Allura Xper FD10C
722003 Allura Xper FD10
722006 Allura Xper FD20
722010 Allura Xper FD10
722012 Allura Xper FD20
722015 Allura Xper Open, Classified |
OWB | None listed |
| Dec 15, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion systems with monoplane fixed ceiling mounts:
722078 Azurion 7 M12
722079 Azurion 7 M20
722223 Azurion 7 M12
722224 Azurion 7 M20
722227 Azurion 5 M12
722228 Azurion 5 M20 Open, Classified |
OWB | None listed |
| Sep 14, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems Open, Classified |
OWB | None listed |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. Azurion Open, Classified |
OWB | None listed |
| Aug 30, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems Open, Classified |
OWB | None listed |
| Aug 2, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20. X-ray Image guided Therapy System. Open, Classified |
OWB | None listed |
| Feb 2, 2022 | Philips Healthcare Philips StentBoost Live R2.0 application, when used with the
Philips Azurion with software release R2.x Terminated |
OWB | None listed |
| Jan 10, 2022 | Philips North America Llc Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System .
Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722 Open, Classified |
OWB | None listed |
| Sep 24, 2021 | Philips Healthcare Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Open, Classified |
OWB | None listed |
| May 26, 2021 | Philips Healthcare Azurion systems with software release R2.0.x Completed |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.