Data / Medical devices / Netherlands / Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.: FDA-registered device maker in BEST Noord-Brabant, Netherlands, 17 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3003768277) in BEST Noord-Brabant, Netherlands. It lists 36 device types. The FDA files 17 510(k) clearances under its listings, the newest dated March 3, 2022. 54 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003768277
- FEI number
- 3002807880
- Address
- Veenpluis 6, BEST Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Contract manufacturer, Exporter to the US, Remanufacturer
- First device listed
- March 30, 1978
- Registered through
- 2026
- Brand names listed
- 001014 - 2D Quantitative Analysis, 1.5 T eCoil Imaging System for Philips, 3D Roadmap Rel. 1, 3D-CA, 3D-RA, ADVANCED FILTER ECG CABLE - 989803170121, ALLURACLARITY XPER FD SERIES X-RAY SYSTEM, ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2022 | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| July 10, 2020 | K201389 | Resoundant Acoustic Driver System | LNH | Substantially Equivalent | Resoundant, Inc. | accessdata.fda.gov |
| September 14, 2018 | K173926 | DORADOnova MR3T | IYE | Substantially Equivalent | Lap GmbH Laser Applikationen | accessdata.fda.gov |
| March 21, 2018 | K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
| August 6, 2014 | K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| July 15, 2013 | K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| June 28, 2013 | K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 26, 2010 | K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | MWI | Substantially Equivalent | Witt Biomedical Corp | accessdata.fda.gov |
| July 28, 2010 | K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 | MOS | Substantially Equivalent | Shanghai Chenguang Medical Technologies Co, Ltd. | accessdata.fda.gov |
| July 14, 2010 | K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 | MOS | Substantially Equivalent | Shanghai Chenguang Medical Technologies Co, Ltd. | accessdata.fda.gov |
| December 15, 2009 | K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | MWI | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| July 21, 2008 | K081218 | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST | IYE | Substantially Equivalent | It-V Medizintechnik, GmbH | accessdata.fda.gov |
| June 18, 2008 | K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | MOS | Substantially Equivalent | Shanghai Chenguang Medical Technologies Co, Ltd. | accessdata.fda.gov |
| June 18, 2008 | K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL | MOS | Substantially Equivalent | Shanghai Chenguang Medical Technologies Co, Ltd. | accessdata.fda.gov |
| July 23, 2007 | K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL | MOS | Substantially Equivalent | Shanghai Chenguang Medical Technologies Co, Ltd. | accessdata.fda.gov |
| November 30, 2006 | K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS | MOS | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 26, 1990 | K903390 | MEDRAD MARK V-PLUS INJECTOR | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | 99223 | Class II | Ongoing | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for | 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 | accessdata.fda.gov |
| March 19, 2026 | 98576 | Class II | Ongoing | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data. | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinic | accessdata.fda.gov |
| March 5, 2026 | 98520 | Class II | Ongoing | Vue Motion V12. Product Number: 1017979. | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. | accessdata.fda.gov |
| January 26, 2026 | 98326 | Class II | Ongoing | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. | accessdata.fda.gov |
| December 15, 2025 | 98109 | Class II | Ongoing | Product Name: Allura Xper FD10C; Model number: 722001 | 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 installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-ci | accessdata.fda.gov |
| December 12, 2025 | 98108 | Class II | Ongoing | Philips Azurion system; Software Version Number: R3.1 | Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Po | accessdata.fda.gov |
| December 12, 2025 | 98096 | Class II | Ongoing | 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 M15. Model Numbers: 72 | Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error. | accessdata.fda.gov |
| December 8, 2025 | 98071 | Class II | Ongoing | Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. | Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker | accessdata.fda.gov |
| October 2, 2025 | 97719 | Class II | Ongoing | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234 | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the frictio | accessdata.fda.gov |
| September 29, 2025 | 97682 | Class II | Ongoing | Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system | Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board. | accessdata.fda.gov |
| September 3, 2025 | 97502 | Class II | Ongoing | Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563 | 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 battery is low on power or depleted. | accessdata.fda.gov |
| September 3, 2025 | 97501 | Class II | Ongoing | Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949 | 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 unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational f | accessdata.fda.gov |
| August 1, 2025 | 97359 | Class II | Ongoing | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. | accessdata.fda.gov |
| August 1, 2025 | 97249 | Class II | Ongoing | 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 M15, Model Number 722064. | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. | accessdata.fda.gov |
| June 30, 2025 | 97155 | Class II | Ongoing | 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. Allura Xper FD20/10, Model Nu | Potential for temporary loss of imaging (X-ray) functionality due to software issue. | accessdata.fda.gov |
| June 4, 2025 | 97055 | Class II | Ongoing | Azurion 7 M20. Fluoroscopic X-Ray System. | Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. | accessdata.fda.gov |
| May 28, 2025 | 96962 | Class II | Ongoing | 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) 722227, (14) 722228, ( | A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the p | accessdata.fda.gov |
| March 24, 2025 | 96728 | Class II | Ongoing | Enterprise 1.5T, Model Number: 781145 | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury. | accessdata.fda.gov |
| January 13, 2025 | 96132 | Class I | Ongoing | Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026 | Possibility of the patient falling from the table related to the mattress used on the patient table. | accessdata.fda.gov |
| January 13, 2025 | 96120 | Class II | Ongoing | Allura CV20 System Code: 722031 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service | accessdata.fda.gov |
| November 11, 2024 | 95713 | Class II | Ongoing | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 B | Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may c | accessdata.fda.gov |
| October 7, 2024 | 95579 | Class II | Ongoing | Philips Zenition 50, Model Number: 718096 | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. | accessdata.fda.gov |
| August 22, 2024 | 95256 | Class II | Ongoing | System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurio | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury. | accessdata.fda.gov |
| August 8, 2024 | 95144 | Class II | Ongoing | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 | A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. | accessdata.fda.gov |
| August 6, 2024 | 95148 | Class II | Ongoing | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224 | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the frictio | accessdata.fda.gov |
| July 15, 2024 | 94994 | Class II | Ongoing | Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the follow | Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart | accessdata.fda.gov |
| May 16, 2024 | 94647 | Class II | Ongoing | Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. | accessdata.fda.gov |
| May 2, 2024 | 94593 | Class II | Ongoing | Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. | Potential for pressure wave data synchronization from two devices may not be correct. | accessdata.fda.gov |
| February 6, 2024 | 93966 | Class II | Ongoing | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280 | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure. | accessdata.fda.gov |
| January 2, 2024 | 93783 | Class II | Ongoing | 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: Allura Xper FD10 722003 | 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 result in delay of procedure. | accessdata.fda.gov |
| January 2, 2024 | 93781 | Class II | Ongoing | 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 Xper Model Name - Model | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. | accessdata.fda.gov |
| January 2, 2024 | 93777 | Class II | Ongoing | 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 FD10 722003 722010 722026 | 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. | accessdata.fda.gov |
| December 12, 2023 | 93755 | Class II | Ongoing | Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B1 | System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure. | accessdata.fda.gov |
| December 8, 2023 | 93734 | Class II | Ongoing | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) | Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table. | accessdata.fda.gov |
| December 8, 2023 | 93721 | Class II | Ongoing | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) | Loss of connectivity between the FlexArm and the Table due to a software issue. | accessdata.fda.gov |
| November 3, 2023 | 93416 | Class II | Ongoing | 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 FD20 OR Table 722016 | Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose | accessdata.fda.gov |
| August 15, 2023 | 92901 | Class II | Ongoing | Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. | accessdata.fda.gov |
| June 30, 2023 | 92782 | Class II | Ongoing | Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems | Loss of availability of the wireless foot switch during procedures. | accessdata.fda.gov |
| June 12, 2023 | 92635 | Class II | Ongoing | Allura Xper FD10 and FD20. X-ray Imaging System. | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. | accessdata.fda.gov |
| March 21, 2023 | 92165 | Class II | Ongoing | Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM2 | Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure | accessdata.fda.gov |
| February 20, 2023 | 91806 | Class II | Ongoing | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. | accessdata.fda.gov |
| December 2, 2021 | 89437 | Class II | Ongoing | Zenition 50, Model #718096 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system. | accessdata.fda.gov |
| May 26, 2021 | 89964 | Class II | Ongoing | Azurion systems with software release R1.x | In the Azurion system, the user can add a new study to a patient by selecting the option Add Study. The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure, the Patient Type changes inadvertently to a Patient Type different than the | accessdata.fda.gov |
| March 25, 2019 | 82610 | Class II | Terminated | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the mag | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling. | accessdata.fda.gov |
| February 19, 2019 | 82459 | Class II | Terminated | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neur | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures. | accessdata.fda.gov |
| December 21, 2018 | 82038 | Class II | Terminated | Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | accessdata.fda.gov |
| December 3, 2018 | 81797 | Class II | Terminated | Ingenia Elition S, Ingenia Elition X | During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. | accessdata.fda.gov |
| November 30, 2018 | 83366 | Class II | Terminated | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images. | accessdata.fda.gov |
| May 1, 2018 | 80271 | Class II | Terminated | OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 | The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander. | accessdata.fda.gov |
| March 26, 2018 | 79783 | Class II | Terminated | MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human pat | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user. | accessdata.fda.gov |
| June 23, 2016 | 87978 | Class II | Terminated | Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. | Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. | accessdata.fda.gov |
| February 24, 2012 | 61267 | Not yet classified | Terminated | Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angio | Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values. | accessdata.fda.gov |
| January 27, 2012 | 61043 | Not yet classified | Terminated | Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device. | There maybe incorrect values in the diffusion/perfusion maps. | accessdata.fda.gov |
| March 27, 2011 | 58320 | Not yet classified | Terminated | S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Tr | Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.