510(k) K163715 ยท OWB Interventional Fluoroscopic X-Ray System
Allura Xper R9
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Jan 26, 2017 |
| Received | Dec 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Sep 3, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x).
Labeled as the following with corresponding model numbers:
1. Allura Xper FD10, Model Number 722003
2. Allura Xper 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 |
| 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. 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 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 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: Imaging Processing PC, Host PC, FlexVision PC
Allura X 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.