Philips North America Llc recalls

Philips is recalling 11 ultrasound transducer models to clarify and update labeling that defines how long these devices are expected to remain in use. The recall was filed for clarification, and no injuries have been reported.

FDA·Apr 1, 202611 products

Philips is recalling four Trilogy ventilator models running software version 1.05.15.00: Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal. When non-pneumatic nebulizers are used with these ventilators, the breath volume the patient receives may differ from the amount the device is set to deliver. No injuries have been reported. The recall covers about 113,717 units per model and was distributed nationwide and in many other countries.

Serious·FDA·Apr 1, 20264 products

Philips is recalling eight Azurion 3, 5, and 7 X-ray system models. Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active. No injuries have been reported.

Moderate·FDA·Feb 18, 20268 products

Philips is recalling four CT scanner models because one or more of the 32 fasteners that attach the rotor to the gantry bearing may not be tightened to specification. If several fasteners are loose, rotor parts could become unsecured or displaced, and in theory could be expelled. The company reports no injuries and no observed parts being expelled during gantry rotation.

Moderate·FDA·Feb 18, 20264 products

Philips is recalling 13 MR imaging system products because exported MR Elastography stiffness maps may show incorrect stiffness values when viewed in a PACS image viewer. No injuries have been reported.

Moderate·FDA·Feb 4, 202613 products

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.

Moderate·FDA·Jan 28, 2026

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.

Moderate·FDA·Jan 28, 2026

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.

Moderate·FDA·Jan 21, 2026

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.

Serious·FDA·Jan 21, 2026

Philips is recalling 16 Allura Xper imaging system models because a drip tray under the cooling unit may not have been installed during earlier field corrections, or the installation was not properly documented. Without the tray, coolant could reach electrical components, possibly causing short-circuits, blown fuses, or system shutdown. No injuries have been reported.

Moderate·FDA·Jan 21, 202616 products

Philips MX40 patient monitors may lose wireless connection to the PIC iX central station when moving between certain access points if the signal strength changes rapidly. This could interrupt patient data transmission to clinical staff.

Moderate·FDA·Jan 14, 2026

Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.

Moderate·FDA·Jan 14, 2026

Philips EPIQ Ultrasound Systems with the X5-1c transducer and certain software versions may unexpectedly restart on their own. This automatic reboot can damage the transducer. No injuries have been reported.

Moderate·FDA·Jan 7, 2026

Between July 2024 and June 2025, some Philips Azurion R3.0 fluoroscopic X-ray systems (model 722234) were shipped without a required safety spacer. This spacer ensures the X-ray tube maintains a safe distance from patients during standard fluoroscopy procedures, as required by FDA regulations.

Moderate·FDA·Dec 17, 2025

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

FDA·Dec 10, 2025

Philips is recalling two CT scanner models, the Incisive CT and CT 5300, covering 2,347 units. The tube heat exchanger screws may not be tightened properly after a replacement, so the part could detach and contact other components during scanner rotation, possibly damaging them. No injuries have been reported.

Moderate·FDA·Dec 10, 20252 products

Philips is recalling 22 IntelliVue patient monitor models, including MP and MX series devices, because they may not sound an alarm when they should. The recall covers products distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Dec 10, 202522 products

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 the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

FDA·Dec 3, 2025

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

FDA·Nov 19, 2025

Philips is recalling 6 imaging product lines whose ceiling suspension telescopic carriages were made between July 2024 and June 2025. The carriages may be hard to move up and down by hand, requiring extra force, because of a possible manufacturing issue. No injuries have been reported.

Moderate·FDA·Nov 19, 20256 products