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Philips North America Llc

Philips North America Llc Recalls

All product recalls associated with Philips North America Llc.

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Recall Summary

Total Recalls

1000

Past Year

272

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 1137 recalls

IntelliVue Multi Measurement Server X2 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

Incisive CT (Philips) – Scanner Component Detachment (2025)

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

FDAOct 29, 2025Nationwide• Philips North America Llc

CT 5300 (Philips) – Scanner Component Detachment (2025)

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FDAOct 29, 2025Nationwide• Philips North America Llc

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

FDAOct 27, 2025Nationwide• Philips North America

SimplyGo Mini Battery Kit (Philips) – charging defect (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.

FDAOct 7, 2025Nationwide• Philips Respironics, Inc.

Precision CRF System (Philips) – carriage movement issue (2025)

Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

FDAOct 1, 2025Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

Zenition 50 X-ray System (Philips) – image quality degradation (2025)

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

FDASep 29, 2025MO, TX• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Incisive CT (Philips) – movement control issue (2025)

Laceration Risk

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

FDASep 25, 2025AL, AR, CA +15 more• PHILIPS MEDICAL SYSTEMS

Incisive CT Brazil (Philips) – movement control issue (2025)

Laceration Risk

FDASep 25, 2025AL, AR, CA +15 more• PHILIPS MEDICAL SYSTEMS

CT 5300 (Philips) – movement control issue (2025)

Laceration Risk

FDASep 25, 2025AL, AR, CA +15 more• PHILIPS MEDICAL SYSTEMS

Cardiac Workstation 7000 (Philips) – Power Module Failure (2025)

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

FDASep 12, 2025Nationwide• Philips North America

Cardiac Workstation 5000 (Philips) – Power Module Failure (2025)

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

FDASep 12, 2025Nationwide• Philips North America

Allura Centron (Philips) – Battery Depletion Risk (2025)

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD20/15 OR Table (Philips) – Component Deterioration (2025)

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD20 (Philips) – Component Deterioration (2025)

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD10C (Philips) – Battery Depletion Risk (2025)

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Stay Informed

Philips North America Llc Recalls

Recall Summary

IntelliVue Multi Measurement Server X2 (Philips) – monitoring alarm issue (2025)

Incisive CT (Philips) – Scanner Component Detachment (2025)

CT 5300 (Philips) – Scanner Component Detachment (2025)

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

SimplyGo Mini Battery Kit (Philips) – charging defect (2025)

Precision CRF System (Philips) – carriage movement issue (2025)

Radiography 7300 C (Philips) – carriage movement issue (2025)

ProxiDiagnost N90 (Philips) – carriage movement issue (2025)

DigitalDiagnost 4 (Philips) – carriage movement issue (2025)

CombiDiagnost R90 (Philips) – carriage movement issue (2025)

Zenition 50 X-ray System (Philips) – image quality degradation (2025)

Incisive CT (Philips) – movement control issue (2025)

Incisive CT Brazil (Philips) – movement control issue (2025)

CT 5300 (Philips) – movement control issue (2025)

Cardiac Workstation 7000 (Philips) – Power Module Failure (2025)

Cardiac Workstation 5000 (Philips) – Power Module Failure (2025)

Allura Centron (Philips) – Battery Depletion Risk (2025)

Allura Xper FD20/15 OR Table (Philips) – Component Deterioration (2025)

Allura Xper FD20 (Philips) – Component Deterioration (2025)

Allura Xper FD10C (Philips) – Battery Depletion Risk (2025)