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 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 Feb 12, 2025 to Feb 18, 2026.

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 18, 2026

Brilliance iCT; Product Code (REF): 728306;

FDA Devices Moderate Feb 18, 2026

Spectral CT; Product Code (REF): 728333;

FDA Devices Moderate Feb 18, 2026

IQon Spectral CT; Product Code (REF): 728332;

FDA Devices Moderate Dec 10, 2025

IntelliVue MP90. Product Number: M8010A.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP30. Product Number: M8002A.

FDA Devices Moderate Dec 10, 2025

IntelliVue Patient Monitor MX800. Product Number: 865240.

FDA Devices Moderate Dec 10, 2025

IntelliVue Patient Monitor MX700. Product Number: 865241.

FDA Devices Moderate Dec 10, 2025

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

FDA Devices Moderate Dec 10, 2025

IntelliVue Patient Monitor MX500. Product Number: 866064.

FDA Devices Moderate Dec 10, 2025

IntelliVue Patient Monitor MX850. Product Number: 866470.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP2. Product Number: M8102A.

FDA Devices Moderate Dec 10, 2025

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

FDA Devices Moderate Dec 10, 2025

IntelliVue MP50. Product Number: M8004A.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP80. Product Number: M8008A.

FDA Devices Moderate Dec 10, 2025

IntelliVue Patient Monitor MX100. Product Number: 867033.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP40. Product Number: M8003A.

FDA Devices Moderate Dec 10, 2025

IntelliVue Multi Measurement Server X2. Product Number: M3002A.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP60. Product Number: M8005A.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP5. Product Number: M8105A.

FDA Devices Moderate Dec 10, 2025

IntelliVue MP20. Product Number: M8001A.

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. …

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. …

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728…

FDA Devices Moderate Oct 1, 2025

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3…

FDA Devices Moderate Jul 2, 2025

Spectral CT. Computed tomography X-ray system.

FDA Devices Moderate May 28, 2025

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia 3.0T CX; Model Number: 781271;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia 1.5T CX; Model Number: 781262;

FDA Devices Moderate May 28, 2025

Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia 1.5T S; Model Number: 781347;

FDA Devices Moderate May 28, 2025

Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

FDA Devices Moderate May 28, 2025

Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

FDA Devices Moderate May 28, 2025

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

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 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 Feb 12, 2025

IntelliVue Patient Monitor MX400. Model Number: 866060

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX450. Model Number: 866062

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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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