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 Jul 7, 2021 to Dec 15, 2021.

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 Dec 15, 2021

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product…

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/C…

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT produ…

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or P…

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT p…

FDA Devices Moderate Nov 17, 2021

Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 72222…

FDA Devices Moderate Oct 20, 2021

Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A

FDA Devices Moderate Oct 20, 2021

Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

FDA Devices Moderate Oct 20, 2021

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

FDA Devices Moderate Oct 20, 2021

Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

FDA Devices Moderate Sep 22, 2021

The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including …

FDA Devices Moderate Sep 22, 2021

The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, intervention…

FDA Devices Moderate Sep 22, 2021

The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including…

FDA Devices Moderate Sep 15, 2021

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…

FDA Devices Moderate Sep 15, 2021

SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce…

FDA Devices Moderate Sep 15, 2021

Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…

FDA Devices Moderate Sep 15, 2021

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images…

FDA Devices Moderate Sep 15, 2021

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…

FDA Devices Moderate Sep 15, 2021

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…

FDA Devices Moderate Sep 15, 2021

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional i…

FDA Devices Moderate Sep 15, 2021

Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-section…

FDA Devices Moderate Sep 15, 2021

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images,…

FDA Devices Moderate Sep 15, 2021

Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…

FDA Devices Moderate Sep 15, 2021

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional image…

FDA Devices Moderate Sep 15, 2021

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-…

FDA Devices Moderate Sep 15, 2021

Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838…

FDA Devices Moderate Sep 1, 2021

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional ima…

FDA Devices Moderate Sep 1, 2021

Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …

FDA Devices Moderate Sep 1, 2021

Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …

FDA Devices Moderate Sep 1, 2021

Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional…

FDA Devices Moderate Sep 1, 2021

Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, …

FDA Devices Moderate Sep 1, 2021

Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional image…

FDA Devices Moderate Sep 1, 2021

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional ima…

FDA Devices Moderate Aug 25, 2021

728333 Spectral CT 7500 -Computed Tomography X-ray system

FDA Devices Moderate Aug 25, 2021

728332 IQon Spectral CT-Computed Tomography X-ray system

FDA Devices Moderate Aug 25, 2021

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

FDA Devices Moderate Aug 25, 2021

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

FDA Devices Moderate Aug 25, 2021

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Mod…

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brill…

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Powe…

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity C…

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Onc…

FDA Devices Moderate Jul 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Philips North America, LLC with Zimmer Biomet, Inc. →

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.