PlainRecalls

Philips North America Llc

Compiled from official public sources by the publisher.

404 recalls on record · Latest: Jul 1, 2026

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Agency notice ledger

Federal filing book Philips North America Llc HEAVY-BOOK · SINGLE-AGENCY

#23 of 14,151 · 404 notices · 0.387% archive

  • BOOK 404 notices
  • RANK #23 of 14,151
  • SHARE 0.387% archive
  • AGENCY FDA Devices (404)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 1, 2026
  • PHOTO Bmw

Nearest notice-volume peer: Bmw (4 notice gap)

Philips North America Llc accounts for about 0.387% of the 104,423-notice archive on 404 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Philips North America Llc compares to 14,151 recalling firms

Philips North America Llc ranks 23rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Philips North America Llc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

404 23rd of 14151 higher than 14,128 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Philips North America Llc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Philips North America Llc holds about 0.387% of archive notices alongside 404 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
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 the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
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, body or extremities, in any orientation. (REF) Numbers: 782110
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, body or extremities, in any orientation. (REF) Numbers: 782120
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 professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
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 professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
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 professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
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 professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Devices Moderate Jul 10, 2024

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
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: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
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: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
FDA Devices Critical Jul 3, 2024

SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
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): 781483
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) 782138; (2) 782109; (3) 781356
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): (1) 782116; (2) 782148
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 (2) 782110
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): 781361
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): 781358
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) 781296 (2) 781343
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) 782103 (2) 781377 (3) 781342
FDA Devices Moderate May 29, 2024

Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
FDA Devices Moderate May 29, 2024

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Devices Moderate May 29, 2024

Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
FDA Devices Moderate May 29, 2024

SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
FDA Devices Moderate May 29, 2024

Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
FDA Devices Moderate May 29, 2024

Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
FDA Devices Moderate May 29, 2024

Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Devices Moderate May 29, 2024

SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
FDA Devices Moderate May 29, 2024

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
FDA Devices Moderate May 29, 2024

SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
FDA Devices Moderate May 29, 2024

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
FDA Devices Moderate May 29, 2024

Ingenia 1.5T S Model Number (REF): 781347
FDA Devices Moderate May 29, 2024

AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Devices Moderate May 29, 2024

Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Devices Moderate May 29, 2024

Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
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 REF: 782116
FDA Devices Moderate May 22, 2024

Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA Devices Moderate May 22, 2024

Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117

Philips North America Llc carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Baxter Healthcare Corporation 413 Olympus Corporation of the Americas 414 Biomerieux Inc 422 B Braun Medical Inc 444

Frequently Asked Questions

How many federal recall notices name Philips North America Llc? ▼
PlainRecalls indexes 404 distinct federal recall events naming Philips North America Llc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Philips North America Llc sit among other recalling firms? ▼
Philips North America Llc ranks #23 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Philips North America Llc's notices? ▼
FDA Devices accounts for 404 of this firm's 404 indexed notices.
What product category dominates Philips North America Llc's filing book? ▼
Filings for Philips North America Llc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Philips North America Llc: 404 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Philips North America Llc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026