PlainRecalls

Philips North America, LLC

Compiled from official public sources by the editorial team.

400 recalls on record · Latest: Feb 18, 2026

Philips North America, LLC Recall Insight

Philips North America, LLC appears on 400 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.393% 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 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 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 Oct 2, 2024 to May 28, 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 May 28, 2025

Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

FDA Devices Moderate May 28, 2025

Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

FDA Devices Moderate May 28, 2025

Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

FDA Devices Moderate May 28, 2025

Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146

FDA Devices Moderate May 28, 2025

Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

FDA Devices Moderate May 28, 2025

Product Name: Upgrade to MR 7700; Model Number: 782130;

FDA Devices Moderate May 14, 2025

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Ped…

FDA Devices Moderate Apr 30, 2025

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical pr…

FDA Devices Moderate Apr 30, 2025

Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical…

FDA Devices Moderate Apr 30, 2025

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical p…

FDA Devices Moderate Apr 30, 2025

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

FDA Devices Moderate Apr 23, 2025

Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

FDA Devices Moderate Apr 23, 2025

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX400. Model Number: 866060

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX450. Model Number: 866062

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 Feb 12, 2025

IntelliBridge EC10 Module. Model Number: 865115

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 Dec 4, 2024

SENSE Breast Coil 3.0T 7ch

FDA Devices Moderate Dec 4, 2024

dS Breast 7ch 1.5T

FDA Devices Moderate Dec 4, 2024

dS Breast 16ch 3.0T

FDA Devices Moderate Dec 4, 2024

ST SENSE Breast Coil

FDA Devices Moderate Dec 4, 2024

Mammotrak Interventional Coil 1.5T

FDA Devices Moderate Dec 4, 2024

Mammotrak Diagnostic Coil 3.0T

FDA Devices Moderate Dec 4, 2024

Achieva TX Interventional Coil 3.0T

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 Oct 2, 2024

Ingenia Elition S -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

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,…

FDA Devices Moderate Oct 2, 2024

MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head,…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.