Philips North America Llc

Philips Respironics has identified an issue with Trilogy Evo ventilators when used with certain non-pneumatic nebulizers. The ventilator may deliver a different amount of air to the patient than the setting shows, which could affect treatment effectiveness. Philips is working with health care providers and regulators on a solution.

Philips Azurion 5 M20 X-ray imaging systems may move their patient table unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could occur under certain conditions and pose a risk during medical procedures.

The table on certain Philips Azurion 5 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects 326 units distributed worldwide, including 10 in the United States. No injuries have been reported.

Philips Azurion 7 M20 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This can occur under certain conditions across all software versions (R1.X, R2.X, R3.X). No injuries have been reported.

Philips medical imaging systems (Azurion 7 M12) may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This affects certain software versions across multiple model numbers. No injuries have been reported.

Philips medical imaging systems (Azurion 7 B20) may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is supposed to be engaged. This affects certain software versions across three model numbers distributed worldwide.

The examination table on certain Philips Azurion 7 B12 X-ray imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This could pose a safety risk to patients or staff during procedures. No injuries have been reported.

Philips medical imaging tables (Azurion 3 M15 systems) may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects specific model numbers with software versions R1.X, R2.X, and R3.X.

The table on certain Philips Azurion 3 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could create a safety risk in clinical settings. Philips has identified this issue and is working on a solution.

Philips has recalled three Spectral CT 7500 CT scanner systems because fasteners that secure the rotor inside the gantry may not have been tightened to the correct specification. If multiple fasteners are loose, rotor parts could become unsecured or displaced during operation. No parts have been expelled or injuries reported so far.

Philips has recalled certain Spectral CT imaging systems because fasteners that hold the rotor in place inside the gantry may not be properly tightened. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during operation. No injuries or equipment failures have been reported so far.

Philips has identified that fasteners holding the rotor in place inside certain IQon Spectral CT scanners may not be properly tightened. While no equipment failures or injuries have been reported, loose fasteners could theoretically cause rotor parts to become unsecured during operation.

Philips has recalled certain Brilliance iCT CT scanners because fasteners that secure the rotor inside the gantry may not be tightened to the correct specification. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during scanning. No injuries or incidents have been reported.

Philips SmartPath to dStream MR imaging systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used for clinical assessment. Three units have been identified worldwide.

Philips dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography images are sent to picture archiving systems (PACS). This affects the accuracy of tissue stiffness measurements used in clinical diagnosis.

Philips MR 7700 MRI systems running software versions R11.1 or R12.1 may display incorrect stiffness values when MR Elastography images are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical evaluation.

Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to medical imaging viewing systems. This affects 9 units worldwide. No injuries have been reported.

Philips Ingenia Elition X MRI systems with certain software versions (R11.1 and R12.1) may display incorrect stiffness values when MR elastography maps are exported to a PACS viewer. This could lead to misinterpretation of tissue stiffness measurements used in clinical diagnosis.

Philips Ingenia Elition S MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS (Picture Archiving and Communication System). This could affect the accuracy of tissue stiffness measurements used in clinical evaluation. Five units worldwide have been identified.

Philips has identified a potential error in how stiffness values are displayed when MR Elastography (MRE) images are exported to a PACS viewer on certain Ingenia Ambition X MRI systems. This affects 21 systems worldwide running software versions R11.1 or R12.1. The error could result in incorrect stiffness measurements being shown to clinicians.

Philips has recalled certain Ingenia Ambition S. MRI systems (software versions R11.1 and R12.1) because they may display incorrect stiffness values when MR Elastography images are sent to a PACS (picture viewing system). This could affect the accuracy of medical imaging data used for diagnosis.

Philips has recalled certain Ingenia 3.0T CX MRI systems (software versions R11.1 and R12.1) because stiffness values displayed in exported elastography maps may be inaccurate when viewed in a PACS (Picture Archiving and Communication System). This affects 6 units worldwide, primarily in the United States and Europe.

Philips has identified a software issue in certain Ingenia 3.0T MRI systems that may cause incorrect stiffness values to appear when viewing elastography images on a PACS (picture viewing system). This affects 24 systems worldwide with specific software versions. No injuries have been reported.

Philips has recalled certain Ingenia 1.5T MRI systems with software versions R11.1 and R12.1. When MR Elastography stiffness maps are exported to a PACS viewer, the stiffness values may display incorrectly. This could affect the accuracy of diagnostic information viewed in those systems.

Philips MR systems (Evolution Upgrade 3.0T, software versions R11.1 and R12.1) may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer system. This could affect the accuracy of imaging data used in clinical assessment.

Philips Evolution Upgrade 1.5T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical diagnosis. Three units have been identified worldwide.

Philips released a software update (version 4.5.0) for the Patient Information Center iX that changes how mobile event notifications are filtered. The system makes these changes without alerting users, so staff may not realize their notification settings have been altered.

Philips has identified two software issues in Azurion R3.1 systems that may cause the device to restart continuously, lose X-ray imaging capability, lose motorized movement, display incorrect images, or lose data. One issue affects all models; a second affects only systems with a Poly-G3 frontal stand.

Philips Azurion X-ray imaging systems running software versions R2.1.10 or R2.2.10 may experience six different software problems. These include unexpected system restarts, continuous restart loops, storage space issues, and positioning errors that could affect image quality or system availability.

Philips Medical Systems has recalled Azurion Systems R3.0 due to nine software issues that may cause X-ray loss, system restarts, display problems, or imaging misalignment during procedures. These issues could affect image quality and system reliability in clinical use.