Philips

System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

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 affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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 affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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.

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.

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

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 clinical decisions.

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.