510(k) K162859 ยท OWB Interventional Fluoroscopic X-Ray System
Allura Xper FD series and Allura Xper OR Table series
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Dec 2, 2016 |
| Received | Oct 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058.
Interventional fluoroscopic x-ray system. 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 29, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura R8.2.x Systems. Software Verion: R8.2.x.
1. Allura Xper FD10, Model Number: 722026.
2. Allura Xper FD10/10, Model Number: 722027.
3. Allura Xper FD20, Model Number: 722028.
4. Allu 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 FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. 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. Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/10; Catalog numbers: 722029 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/15; Catalog numbers: 722058 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20; Catalog numbers: 722038 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura CV20; Catalog numbers: 722031 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10C; Catalog number: 722001 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura CV20
System Code: 722031 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10
Catalog
(1) 722003
(2) 722010
(3)722026 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD10/10
System Code:
(1) 722005
(2) 722011
(3) 722027 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10C
System Code:
(1) 722001 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD20
System Code:
(1) 722006
(2) 722012
(3) 722028 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD20 Biplane
System Code:
(1) 722008
(2) 722013 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD20 Biplane OR Table
System Code:
(1) 722020
(2) 722025 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD20 OR Table
System Code:
(1) 722023
(2) 722035 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXperFD20/10
System Code:
(1) 722029 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20
System Code:
(1) 722038 Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXperFD20/15
System Code:
(1) 722058 Open, Classified |
OWB | None listed |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Open, Classified |
OWB | None listed |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100. Open, Classified |
OWB | None listed |
| May 24, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100. Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems.
Allura Xper Model Name - Model Number:
Allura Xper FD1 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 |
| 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: FlexVision PC
Allura Xper Model Name - Model Number:
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 |
| 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. Allura Xper series Open, Classified |
OWB | None listed |
| Aug 2, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10 and FD20. X-ray Imaging System. Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.