PlainRecalls

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.

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX550. Model Number: 866066

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX500. Model Number: 866064

FDA Devices Moderate Dec 25, 2024

Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

FDA Devices Moderate Dec 11, 2024

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

FDA Devices Moderate Dec 4, 2024

dS Breast 16ch 1.5T

FDA Devices Moderate Dec 4, 2024

Mammotrak Interventional Coil 3.0T

FDA Devices Moderate Dec 4, 2024

Mammotrak Diagnostic Coil 1.5T

FDA Devices Moderate Dec 4, 2024

dS Breast 7ch 3.0T

FDA Devices Moderate Dec 4, 2024

ST SENSE Breast Dx Coil

FDA Devices Moderate Dec 4, 2024

SENSE Breast Coil

FDA Devices Moderate Oct 16, 2024

IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVu…

FDA Devices Moderate Oct 9, 2024

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 8661…

FDA Devices Moderate Oct 2, 2024

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 …

FDA Devices Moderate Oct 2, 2024

Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…

FDA Devices Moderate Oct 2, 2024

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…

FDA Devices Moderate Oct 2, 2024

Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…

FDA Devices Moderate Oct 2, 2024

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…

FDA Devices Moderate Oct 2, 2024

Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of …

FDA Devices Moderate Oct 2, 2024

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 …

FDA Devices Moderate Oct 2, 2024

Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…

FDA Devices Moderate Oct 2, 2024

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…

FDA Devices Moderate Oct 2, 2024

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…

FDA Devices Moderate Aug 14, 2024

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…

FDA Devices Moderate Aug 14, 2024

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…

FDA Devices Moderate Aug 14, 2024

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…

FDA Devices Moderate Aug 14, 2024

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…

FDA Devices Critical Jul 3, 2024

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…

FDA Devices Critical Jul 3, 2024

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…

FDA Devices Moderate Jun 12, 2024

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

FDA Devices Moderate Jun 12, 2024

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

FDA Devices Moderate Jun 12, 2024

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

FDA Devices Moderate May 29, 2024

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

FDA Devices Moderate May 29, 2024

MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF):…

FDA Devices Moderate May 29, 2024

Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359

FDA Devices Moderate May 29, 2024

Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1…

FDA Devices Moderate May 29, 2024

SmartPath to dStream for 3.0T Model Number (REF): 782145

FDA Devices Moderate May 29, 2024

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

FDA Devices Moderate May 29, 2024

Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF):…

FDA Devices Moderate May 29, 2024

MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152…

FDA Devices Moderate May 29, 2024

MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

FDA Devices Moderate May 29, 2024

Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF)…

FDA Devices Moderate May 29, 2024

Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295

FDA Devices Moderate May 29, 2024

Achieva 1.5T Initial system Model Number (REF): 781178

FDA Devices Moderate May 29, 2024

MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439

FDA Devices Moderate May 29, 2024

Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781…

FDA Devices Moderate May 29, 2024

Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 7812…

FDA Devices Moderate May 29, 2024

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

FDA Devices Moderate May 29, 2024

Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782…

FDA Devices Moderate May 22, 2024

Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device R…

FDA Devices Moderate May 22, 2024

Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds