Philips North America Llc

Philips has identified an unintended radiation issue affecting Philips Brilliance CT 64 CT scanner systems (Software 4.1.10.x) that could impact equipment performance. The issue affects multiple Philips CT system models including IQon, iCT, Ingenuity, and Brilliance CT 64.

Philips has identified an unintended radiation issue affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could impact equipment performance. The issue affects specific software versions and product codes distributed in the US and US territories.

Philips has identified an unintended radiation issue affecting the IQon Spectral CT and related CT systems (iCT, Ingenuity, and Brilliance CT 64 models). This issue could affect the performance of the equipment. The problem was found in software version 4.7.7.x.

Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.

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.

Certain Philips Avalon FM 30 fetal monitors have an incorrect speaker connector assembly that can allow device cables to be pulled out of the housing. This defect may cause the speaker to stop working intermittently or permanently, which could affect audio output during monitoring.

Certain Philips Avalon FM20 Fetal Monitors have a speaker connector that was assembled incorrectly. This defect can cause cables to pull out of the device housing, which may result in loss of speaker output—either intermittently or permanently. This affects audio alerts that are critical to clinical monitoring.

The hand switch button on certain Philips Allura Xper fluoroscopy systems may not fully release after use. This can result in loss of imaging capability, unintended radiation exposure, or unintended contrast injection during procedures.

The hand switch button on certain Philips MultiDiagnost Eleva X-ray imaging systems may not fully release after use. This malfunction could prevent the system from stopping imaging, potentially leading to unintended radiation exposure or extra contrast dye injection.

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.

Hard drives in Philips Allura X-ray imaging systems may degrade after six years of use, potentially causing loss of imaging capability, motorized movement, or data. Some systems may temporarily restore function after a restart.

Hard drives in Philips Azurion imaging systems may degrade after six years of use, potentially causing loss of imaging capability. In some cases, the system may need to be restarted to restore function temporarily. Philips has identified this issue in multiple Azurion models used in medical facilities.

A rubber hose inside the X-ray tube cooling unit (type CU3101) on certain Philips Integris-Allura systems can degrade and leak oil over time. This reduces cooling performance and causes the system to automatically switch to low-dose mode with a "Tube cooler problem" message that cannot be cleared by restarting. The affected cooling units were manufactured between February 2016 and May 2020.

A cooling hose in certain Philips Allura X-ray systems manufactured between February 2016 and May 2020 may degrade over time and leak oil. If oil leakage reduces cooling performance below a safe threshold, the system automatically switches to low-dose fluoroscopy and cannot be fixed by restarting.

A cooling hose in certain Philips Azurion X-ray systems may degrade over time and leak oil, reducing cooling performance. When oil levels drop too far, the system automatically switches to low-dose mode and cannot be fixed by restarting.

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.

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.

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.

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.

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.

Philips has identified a problem with the wired foot switch on certain Azurion 5 M20 X-ray imaging systems where the X-ray may not start or may start and stop unexpectedly. This affects 920 systems worldwide, including 168 in the U.S. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Azurion 5 M12 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This affects specific system serial numbers distributed worldwide. No injuries have been reported.

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 M20 X-ray imaging systems. The foot switch may fail to initiate X-ray imaging or cause imaging to occur intermittently, which could affect patient care and diagnostic imaging procedures.

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 M12 X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start and stop intermittently. This affects approximately 1,994 systems sold worldwide, including 360 in the U.S.

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 B20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to stop and restart intermittently during use. This affects approximately 1,500 units worldwide, including about 320 in the United States.

Philips has identified a problem with the wired foot switch on certain Azurion 7 B12 X-ray imaging systems. The foot switch may fail to start X-ray imaging or may cause imaging to occur intermittently, which could affect clinical workflow. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Azurion 3 M15 X-ray imaging systems where X-ray imaging may not start or may work intermittently. This affects specific serial numbers of the system manufactured by Philips Medical Systems Nederland B.V. and distributed worldwide.

Philips identified a problem with the wired foot switch on certain Azurion 3 M12 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work intermittently. About 298 systems worldwide are affected, including 27 in the U.S.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/15 operating room tables. When using the foot switch, X-ray imaging may not start or may stop and start unexpectedly. This affects a small number of systems worldwide.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/15 X-ray imaging systems where the X-ray may not start or may start and stop unexpectedly. This affects 296 systems distributed worldwide, including 68 in the US. No injuries have been reported.