HeartNavigator
Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
5manufacturers in China registered for this device type
2catalogue 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 | 2025-12-15 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HeartNavigator – 2 | In distribution | |
| HeartNavigator – 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| 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 |
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
5 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 | 2024-01-02 | Class II | Process design | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may r | 1,993 US; 2,662 OUS |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2024-01-02 | Class II | Process design | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may r | 1,993 US; 2,662 ROW |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2024-01-02 | Class II | Process design | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. | 13, 133 (3,408 US; 9,725 ROW) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2024-01-02 | Class II | Process design | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. | 13, 133 (3,408 US; 9,725 ROW) |
| Philips Medical Systems Nederland B.V. | UDI-DI | 2024-01-02 | Class II | Process design | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. | 5,500 (1,681 US; 3,819 ROW) |
Recalls
40 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 |
| 2026-06-29 | Class II | Software design | Firmware issue potentially leading to loss of geometry movements. | 4,252 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. | 5,012 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 | |
| 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 | 3314 units (816 US, 2498 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. | 296 units (68 US, 228 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. | 5 units (OUS only) |
| 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. | 461 units (198 US, 263 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. | 111 units (31 US, 80 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. | 5084 units (1616 US, 3468 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. | 85 units (20 US, 65 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. | 2 units (2 US, 6 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. | 2291 units (493 US, 1798 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. | 196 units (73 US, 223 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. | 4 units (2 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. | 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. | 2 units (1 US, 1 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) |
| 2026-03-03 | 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) |
| 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.