Philips Medical Systems Nederland B.v. recalls
59 recalls in our records from 2022 to 2026: 59 FDA medical devices.
Recalls with full detail pages
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10 - Catalog numbers
Possibility of the patient falling from the table related to the mattress used on the patient table.
Earlier and other recalls
These link to the official agency notice.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion Official notice ↗
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2)…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion Rystem Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD. Model Numbers: 722026 Official notice ↗
Firmware issue potentially leading to loss of geometry movements.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura under the following System Descriptions and… Official notice ↗
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
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Philips Medical Systems Nederland B.v. medical device recall: Philips MultiDiagnost Eleva with the following Model Numbers: Model #… Official notice ↗
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion 3M12 Official notice ↗
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap…
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Philips Medical Systems Nederland B.v. medical device recall: Azurion system Official notice ↗
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.…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion systems not configured with an optional auxiliary pan… Official notice ↗
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop…
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Philips Medical Systems Nederland B.v. medical device recall: Azurion system Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion. System Code Description Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a… Official notice ↗
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not…
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Philips Medical Systems Nederland B.v. medical device recall: Vue Motion V12. Product Number: 1017979 Official notice ↗
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10C Official notice ↗
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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Philips Medical Systems Nederland B.v. medical device recall: Azurion 3 M12 System Model Numbers Official notice ↗
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion system Official notice ↗
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,…
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Philips Medical Systems Nederland B.v. medical device recall: Product Name: Allura Xper FD10C Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion Systems with software versions R2.1.10 and R2.2.10.… Official notice ↗
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,…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion Systems R3.0. Includes the following label… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system.… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Zenition 50 Official notice ↗
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)…
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10C Official notice ↗
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,…
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10 Product Codes Official notice ↗
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…
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Philips Medical Systems Nederland B.V. medical device recall: IntelliSpace Cardiovascular Official notice ↗
Software issue that results in the display of outdated information.
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Philips Medical Systems Nederland B.v. medical device recall: Interventional Fluoroscopic X-Ray System - Philips Allura Xper… Official notice ↗
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion System configured with a 1 Phase UPS. Azurion family Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura… Official notice ↗
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
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Philips Medical Systems Nederland B.v. medical device recall: Azurion 7 M20. Fluoroscopic X-Ray System Official notice ↗
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
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Philips Medical Systems Nederland B.v. medical device recall: Azurion R1.x and R2.x systems Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Enterprise 1.5T Official notice ↗
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…
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Philips Medical Systems Nederland B.V. medical device recall: IntelliSpace Cardiovascular software versions 6.x Official notice ↗
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
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Philips Medical Systems Nederland B.V. medical device recall: Zenition 70. The device is to be used in health care facilities both… Official notice ↗
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
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Philips Medical Systems Nederland B.V. medical device recall: Spectral CT on Rails Official notice ↗
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
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Philips Medical Systems Nederland B.V. medical device recall: Philips IntelliSpace Cardiovascular software Official notice ↗
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
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Philips Medical Systems Nederland B.v. medical device recall: Allura CV20 System Code: 722031 Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper Systems Official notice ↗
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,…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Zenition 50 Official notice ↗
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
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Philips Medical Systems Nederland B.v. medical device recall: System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper systems Official notice ↗
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion Interventional Fluoroscopic X-ray System with… Official notice ↗
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper FD20 system with an ADN7NT patient table. Model… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Interventional Hemodynamic Application R.1.2X Official notice ↗
Potential for pressure wave data synchronization from two devices may not be correct.
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Philips Medical Systems Nederland B.v. medical device recall: Azurion 3 with a Certeray generator -To perform image guidance in… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems Official notice ↗
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.…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems Official notice ↗
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems Official notice ↗
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.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion system Official notice ↗
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,…
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Philips Medical Systems Nederland B.v. medical device recall: Azurion 7 M20 FlexArm system Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Azurion 7 M20 FlexArm system Official notice ↗
Loss of connectivity between the FlexArm and the Table due to a software issue.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura systems with monoplane fixed ceiling mounts: 722001… Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Philips Allura Xper Official notice ↗
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
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Philips Medical Systems Nederland B.V. medical device recall: Allura Xper series Official notice ↗
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
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Philips Medical Systems Nederland B.v. medical device recall: Wireless Foot Switch distributed with Philips Allura Xper and Azurion… Official notice ↗
Loss of availability of the wireless foot switch during procedures.
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10 and FD20. X-ray Imaging System Official notice ↗
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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Philips Medical Systems Nederland B.v. medical device recall: Philips Azurion System with software versions: R2.2.O Official notice ↗
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
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Philips Medical Systems Nederland B.v. medical device recall: SmartPerfusion Official notice ↗
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
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Philips Medical Systems Nederland B.v. medical device recall: Azurion systems with software release R1.x Official notice ↗
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…
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Philips Medical Systems Nederland B.v. medical device recall: Zenition 50 Official notice ↗
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…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.