Allura Xper FD
Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (10-inch or 20-inch flat detector) and interface for an OR table.
5manufacturers in China registered for this device type
21catalogue numbers in this listing
29510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-09-26 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Distribution end date | 2019-09-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Allura Xper FD20 OR Table | In distribution | |
| Allura Xper FD20 Biplane OR Table | In distribution | |
| Allura Xper FD10 | In distribution | |
| Allura Xper FD20 | In distribution | |
| Allura Xper FD20 | In distribution | |
| Allura Xper FD20/20 | In distribution | |
| Allura Xper FD20/10 | In distribution | |
| Allura Xper FD10 | In distribution | |
| Allura Xper FD20/10 OR Table | In distribution | |
| Allura Xper FD20 OR Table | In distribution | |
| Allura Xper FD10/10 OR Table | In distribution | |
| Allura Xper FD10 OR Table | In distribution | |
| Allura Xper FD20 Biplane | In distribution | |
| Allura Xper FD20/15 | In distribution | |
| Allura Xper FD20/20 OR Table | In distribution | |
| Allura Xper FD20/15 OR Table | In distribution | |
| Allura Xper FD10/10 | In distribution | |
| Allura Xper FD10/10 OR Table | In distribution | |
| Allura Xper FD10 OR Table | In distribution | |
| Allura Xper FD10/10 | In distribution | |
| Allura Xper R9 7 M12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254205 | 2026-08-07 |
| K232420 | 2024-02-16 |
| K212813 | 2021-10-01 |
| K201583 | 2021-02-09 |
| K200917 | 2020-05-01 |
| K183101 | 2018-12-31 |
| K183040 | 2018-12-06 |
| K181830 | 2018-08-02 |
| K172822 | 2017-11-22 |
| K172307 | 2017-10-24 |
| K170130 | 2017-06-02 |
| K163715 | 2017-01-26 |
| K162859 | 2016-12-02 |
| K160455 | 2016-08-25 |
| K160147 | 2016-08-10 |
| K161563 | 2016-07-29 |
| K161839 | 2016-07-29 |
| K151598 | 2015-08-17 |
| K142273 | 2015-01-30 |
| K142126 | 2014-12-09 |
| K133819 | 2014-07-10 |
| K140138 | 2014-06-10 |
| K133292 | 2014-03-05 |
| K132147 | 2013-12-16 |
| K132305 | 2013-10-30 |
| K130893 | 2013-09-06 |
| K131263 | 2013-07-24 |
| K130638 | 2013-06-28 |
| K121772 | 2013-03-21 |
Recalls Naming This Product
73 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-06-29 | Class II | Software design | Firmware issue potentially leading to loss of geometry movements. | 4,252 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-06-17 | Class II | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | 5,012 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-04-30 | Class II | Under Investigation by firm | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the aff | |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-04-28 | Class II | Component design/selection | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. Whe | 3314 units (816 US, 2498 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 2291 units (493 US, 1798 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 112 units (138 US, 422 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 5084 units (1616 US, 3468 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 461 units (198 US, 263 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 196 units (73 US, 223 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 4 units (2 US, 2 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 2 units (1 US, 1 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 85 units (20 US, 65 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 111 units (31 US, 80 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 5 units (OUS only) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 296 units (68 US, 228 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 2 units (2 US, 6 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 56 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 21 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 79 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 23 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 4 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 95 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 22 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 2 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 4 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-12-15 | Class II | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not ins | 8 units |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 2317 units (497 US, 1820 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 585 units (145 US, 440 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 2 units (1 US, 1 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 5067 units (1626 US, 3441 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 501 units (212 US, 289 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 4 units (2 US, 2 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 298 units (72 US, 226 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 87 units (21 US, 66 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 300 units (69 US, 231 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 8 units (2 US, 6 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 115 units (34 US, 81 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the ba | 5 units (OUS only) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailab | 1117 units (252 US, 865 OUS) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2025-09-03 | Class II | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailab | 286 units (67 US, 219 OUS) |
Showing 40 of 73.
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-16 | Class II | Software design | Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geo | 2016 units |
| 2026-07-16 | Class II | Software design | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements | 10872 units |
| 2026-06-17 | Class II | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | 3,341 units |
| 2026-06-17 | Class II | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | 257 units |
| 2026-05-18 | Class II | Radiation Control for Health and Safety Act | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection | |
| 2026-04-30 | Class II | Under Investigation by firm | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the aff | 3069 units (872 US, 2224 OUS) |
| 2026-04-28 | Class II | Component design/selection | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. Whe | 25 units (11 US, 14 OUS) |
| 2026-04-28 | Class II | Component design/selection | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. Whe | 1651 units (592 US, 1359 OUS) |
| 2026-04-28 | Class II | Device Design | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. | 5,537 units |
| 2026-03-31 | Class II | Device Design | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. | 1,718 units |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 1523 units (322 US, 1201 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 345 units (10 US, 335 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 10 units (8 US, 2 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 920 units (168 US, 752 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 5167 units (1728 US, 3439 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 670 units (106 US, 564 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 798 units (42 US, 756 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 298 units (27 US, 271 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 1994 units (360 US, 1634 OUS) |
| 2026-03-03 | Class II | Device Design | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | 15 units (7 US, 8 OUS) |
| 2026-01-26 | Class II | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed – even when a table lock is active. | 291 units (27 US, 264 OUS) |
| 2026-01-26 | Class II | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed – even when a table lock is active. | 802 units (45 US, 757 OUS) |
| 2026-01-26 | Class II | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed – even when a table lock is active. | 655 units (106 US, 549 OUS) |
| 2026-01-26 | Class II | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed – even when a table lock is active. | 1503 units (326 US, 1177 OUS) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.