Philips North America, LLC
275 recalls on record · Latest: Feb 18, 2026
Philips North America, LLC Recall Insight
Philips North America, LLC appears on 275 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.328% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 2 critical, 48 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 22, 2024 to Feb 12, 2025.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
IntelliVue Patient Monitor MX550. Model Number: 866066
IntelliVue Patient Monitor MX500. Model Number: 866064
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
dS Breast 16ch 1.5T
Mammotrak Interventional Coil 3.0T
Mammotrak Diagnostic Coil 1.5T
dS Breast 7ch 3.0T
ST SENSE Breast Dx Coil
SENSE Breast Coil
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVu…
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 8661…
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 …
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of t…
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
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 in…
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of …
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal …
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
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 h…
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care prof…
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care prof…
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care pro…
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care prof…
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567…
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 4535673…
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF):…
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1…
SmartPath to dStream for 3.0T Model Number (REF): 782145
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF):…
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152…
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF)…
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
Achieva 1.5T Initial system Model Number (REF): 781178
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781…
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 7812…
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782…
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device R…
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
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