510(k) K172822 ยท OWB Interventional Fluoroscopic X-Ray System
Azurion series R1.2
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Nov 22, 2017 |
| Received | Sep 18, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172822
| 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 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 |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10 -
Catalog numbers: (1) 722003, (2) 722010, (3) 722026, Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. 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 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 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 |
| 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 |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. Azurion Open, Classified |
OWB | None listed |
| May 3, 2022 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion systems with software release R1.x 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 |
| 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 |
| Jul 16, 2019 | Philips North America, LLC Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows:
Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20
Mod Terminated |
OWB | None listed |
| Nov 30, 2018 | Philips Medical Systems Nederlands Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.