Manufacturer

Philips North America Llc

306 recalls in our database name Philips North America Llc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 306

HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2025·2024-12-04
Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk
Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.
Product
Achieva TX Interventional Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2025·2024-12-04
Philips SENSE Breast Coil Recall for Potential Patient Safety Hazard
Philips is recalling 5,231 SENSE Breast Coils due to a potential patient safety hazard during scan preparation and performance. The FDA has not disclosed specific details about the nature of the risk.
Product
SENSE Breast Coil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2025·2024-12-04
Mammotrak Interventional Coil 1.5T recalled for patient safety risk
Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.
Product
Mammotrak Interventional Coil 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2025·2024-12-04
Mammotrak Diagnostic Coil 1.5T Recalled Due to Patient Safety Concern
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
Product
Mammotrak Diagnostic Coil 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0543-2025·2024-12-04
Philips Mammotrak Diagnostic Coil 3.0T Recall Due to Patient Safety Risk
Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.
Product
Mammotrak Diagnostic Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2025·2024-12-04
Philips Breast MRI System Recalled for Patient Safety Risk
Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.
Product
dS Breast 7ch 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2025·2024-12-04
Philips dS Breast 16ch 1.5T MRI Recalled for Patient Safety Risk
Philips North America is recalling approximately 5,231 dS Breast 16ch 1.5T MRI systems nationwide due to a potential safety issue that could harm patients during scan preparation or procedures.
Product
dS Breast 16ch 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2025·2024-12-04
Philips dS Breast 7ch 3.0T MRI Coil Recalled for Patient Safety Hazard
Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.
Product
dS Breast 7ch 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2025·2024-12-04
Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk
Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.
Product
ST SENSE Breast Coil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0544-2025·2024-12-04
Philips Mammotrak Interventional Coil MRI Device Recalled for Patient Safety
Philips recalls 5,231 Mammotrak Interventional Coil 3.0T MRI devices nationwide due to a potential safety issue that could harm patients during scan preparation or imaging.
Product
Mammotrak Interventional Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2025·2024-12-04
Philips ST SENSE Breast Imaging Coil Recalled for Patient Safety Risk
Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.
Product
ST SENSE Breast Dx Coil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2025·2024-12-04
SENSE Breast Coil 3.0T recalled due to potential patient safety hazard
Philips is recalling approximately 5,231 SENSE Breast Coil 3.0T units due to a potential safety hazard that could harm patients during MRI scanning procedures.
Product
SENSE Breast Coil 3.0T 7ch
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2025·2024-12-04
Philips dS Breast MRI System Recalled for Patient Safety Hazard
Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.
Product
dS Breast 16ch 3.0T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2025·2024-10-16
Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms
Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.
Product
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indica
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3312-2024·2024-10-09
Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring
Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.
Product
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3197-2024·2024-10-02
MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Product
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3195-2024·2024-10-02
Philips Ingenia 3.0T MRI Scanner Tabletop Blockage Risk
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
Product
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3200-2024·2024-10-02
MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Product
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 78213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3194-2024·2024-10-02
Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
Product
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3199-2024·2024-10-02
MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment
Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.
Product
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide