Philips North America Llc recalls

Philips Medical Systems Nederland B.V. is recalling Allura Xper systems running software releases R8.1.x or R8.2.x that are configured with a FlexVision monitor. The software issue may cause the FlexVision software application to become unresponsive during clinical use.

Moderate·FDA·Nov 6, 2026

Philips is recalling 9 Azurion imaging system models, including Azurion 3, 5, 7 and S configurations. Some of these PCs may contain solid-state drives (SSDs) that are not specified in the Medical Device File, which could lead to reduced reliability over time, such as loss of imaging, a blank or black display, or trouble storing or accessing images. No injuries have been reported. The recall covers units distributed in the US and many other countries.

Moderate·FDA·Oct 27, 20269 products

Philips North America has recalled Model 712010 devices due to a potential for the device to fail immediately after exposure, which could cause the system to stop working. Approximately 563 units are affected.

Moderate·FDA·Oct 26, 2026

Philips Smart-hopping 2.0 AP wireless access points may experience unreliable roaming behavior when older Smart-hopping 1.0 wireless clients move between locations. This can cause loss of connection to the central monitoring system, potentially interrupting patient monitoring in healthcare facilities.

Moderate·FDA·Oct 16, 2026

The Philips Lumify portable ultrasound system may fail to recognize previously saved transducer settings, forcing re-registration that requires Wi-Fi or cellular access—unavailable in ambulances, aircraft, or remote field settings. Additionally, the USB cable connection between the transducer and tablet/phone may become unstable or disconnect, disrupting scans. These issues could delay diagnosis or treatment.

Serious·FDA·Oct 16, 2026

Philips Medical Systems has recalled certain Spectral CT and Spectral CT 7500 RT imaging systems due to software problems. These issues may cause image artifacts, incorrect slice thickness, or unintended movement of the system during operation.

Moderate·FDA·Oct 14, 2026

Philips is recalling 12 MR imaging system products and related upgrades because diffusion tensor imaging (DTI) scans exported in the Enhanced MR DICOM format can contain incorrect diffusion direction data. When that export is used with third-party tractography software, the software may not be able to correctly process the data for reconstruction. No injuries have been reported.

Moderate·FDA·Oct 7, 202612 products

The bolus tracking application on Philips Spectral CT 7500 scanners (Software V5.2.x) can malfunction and continue taking imaging shots even after reaching the contrast threshold. This can cause patients to receive unintended additional radiation during CT scans.

Moderate·FDA·Oct 7, 2026

A software issue in Philips EPIQ Elite ultrasound systems (Model 795234, software version 14.0) causes doppler blood flow measurements to display at incorrect depths. This can lead to inaccurate velocity readings and potential misdiagnosis of vascular conditions. About 219 units are affected worldwide.

Moderate·FDA·Sep 30, 2026

Philips is recalling 12 groups of MRI systems and related upgrade products because of a software issue. If scan settings are manually adjusted so the image processing needs more memory than the system has, the examination can end partway through. No injuries have been reported.

Moderate·FDA·Sep 30, 202612 products

Philips is recalling two patient information system products because a software malfunction can cause the system to freeze and stop responding. The recall includes 7,671 affected units across the two products, which were distributed in the US and internationally. No injuries have been reported.

Moderate·FDA·Sep 23, 20262 products

Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

Moderate·FDA·Sep 9, 20264 products

Philips Incisive CT scanners running software versions V4.5 or V5.0 may fail to start a clinical scan during Bolus Tracking imaging procedures. This could delay or prevent necessary diagnostic scans from being acquired.

Moderate·FDA·Sep 2, 2026

The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 20262 products

Philips is recalling certain Azurion interventional fluoroscopic X-ray systems, model numbers 722229 through 722236, running software versions R3.0 and R3.1. The software can degrade image quality, and it can also cause loss of geometry movements, which may delay treatment or complicate procedures. No injuries have been reported.

Moderate·FDA·Aug 19, 2026

Philips is recalling certain Azurion interventional fluoroscopic X-ray systems running software version R2.2.10. The software can degrade image quality or cause a loss of geometry movements, which may delay treatment or lead to procedural complications. No injuries have been reported.

Moderate·FDA·Aug 19, 2026

Philips Medical Systems recalled certain Allura Xper FD interventional fluoroscopic X-ray systems, affecting about 4,252 units. A firmware problem may cause the system to lose some geometry movements. No injuries have been reported.

Moderate·FDA·Aug 19, 2026

Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.

Moderate·FDA·Jul 1, 2026

Philips is recalling two Avalon fetal monitor models, the FM20 and FM30, because the speaker connector may have been assembled incorrectly. Device cables can be pulled out of the housing, which may cause intermittent or permanent loss of speaker output. The recall includes 454 affected units, and no injuries have been reported.

Moderate·FDA·Jul 1, 20262 products

Philips is recalling two imaging systems used in medical settings, the Allura Xper and MultiDiagnost Eleva, covering 2 product entries. The hand switch button may not fully release after use, which could cause loss of imaging function or unintended radiation exposure and extra contrast injection. No injuries have been reported.

Moderate·FDA·Jun 24, 20262 products

One Philips DigitalDiagnost C90 Flex/Value/Chest/ER X-ray system was shipped without the required Seismic kit for its Wall Stand VS2. The kit is designed to keep the stand stable and prevent damage during earthquakes or seismic events.

Moderate·FDA·Jun 17, 2026

Philips is recalling Azurion and Allura imaging systems because the hard drives in their PCs may slow down as they age, especially after six years of use. Depending on the system, this can cause loss of imaging function, and in Allura systems it may also cause loss of motorized movement or data loss. A system restart may temporarily restore function. No injuries have been reported, and the recall covers 2 product lines with about 3,069 affected units.

Moderate·FDA·Jun 3, 20262 products

Philips is recalling X-ray tube cooling units, type CU3101, that were made between February 2016 and May 2020. The deaeration hose may degrade and leak oil, which can reduce cooling. When oil flow drops too low, the system switches to low-dose fluoroscopy and shows a tube cooler message that restarting does not clear. The recall covers 3 product lines with about 5,000 affected units, and no injuries have been reported.

Moderate·FDA·May 27, 20263 products

Certain Philips Azurion fluoroscopy systems may experience mechanical wear in the Float Tabletop control, which could impair the longitudinal and transverse (side-to-side and front-to-back) movement of the examination table. This wear could affect the system's ability to position patients correctly during imaging procedures.

Moderate·FDA·May 27, 2026

Bolts and plastic parts on the Cable Hose Carriers that attach cable hoses to the monitor ceiling suspension may loosen or break over time when the monitor is moved or rotated. This affects multiple Azurion 3, 5, and 7 model variants.

Moderate·FDA·May 20, 2026

Philips has identified three software issues in the Spectral CT on Rails Model 728334 that may affect scan operations. The gantry (rotating scanner) may not move to the correct position after pressing start; a required confirmation message may not appear; and a menu option may become unavailable during brain imaging setup. Three systems worldwide are affected.

Moderate·FDA·Apr 22, 2026

Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.

Moderate·FDA·Apr 22, 2026

Philips Vue Motion V12 cardiac imaging software (Product Number 1017979, software versions 12.2.0 through 12.2.8.500) may display image frames out of sequence during dynamic cine runs. This could cause medical staff to review cardiac images in the wrong order, potentially affecting diagnosis.

Moderate·FDA·Apr 8, 2026

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

Moderate·FDA·Apr 8, 202622 products

Philips is recalling four Trilogy ventilator models running Software Version 1.05.15.00, covering 113,717 units in total. In some situations, the Obstruction Alarm does not sound within the time required by applicable standards and may take up to four breaths to trigger. No injuries have been reported.

Serious·FDA·Apr 8, 20264 products