Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Philips medical devices: approvals, recalls and adverse events

Stock: PHG. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

1,263

De Novo: 2

PMA approvals

341 supplements

Recalled products

2,420

130 class I

Adverse event reports

634K

10,853 deaths reported

How many recalls does Philips have?

Philips has 2,420 recalled medical device products in 915 recall actions in the records, 130 of them class I (the most serious kind). The newest recall started on Aug 28, 2026. In 2025 it had 345 recalled products.

How many medical devices has Philips had cleared or approved?

1,263 510(k) clearances, 2 De Novo grants and 12 original PMA approvals for high-risk devices, plus 341 PMA supplements (changes to approved devices). The newest decision was on Sep 3, 2026.

How many adverse event reports name Philips devices?

634,362 reports in total: 10,853 deaths, 64,410 injuries and 556,662 malfunctions were reported. 94,767 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	27	0	0	10
2025	36	0	0	13
2024	27	0	0	13
2023

Newest clearances and approvals

Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)
K261622 · 510(k) clearance · Sep 3, 2026
Zenition 30
K254205 · 510(k) clearance · Aug 7, 2026
Alturion Series Diagnostic Ultrasound System
K262311 · 510(k) clearance · Aug 4, 2026
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
K262330 · 510(k) clearance · Jul 30, 2026
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
K261211 · 510(k) clearance · Jul 27, 2026
dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T
K262294 · 510(k) clearance · Jul 24, 2026
SmartCT (R3.0 (L10))
K253670 · 510(k) clearance · Jul 10, 2026
Alturion Series Diagnostic Ultrasound System
K260667 · 510(k) clearance · Jun 29, 2026
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
K252821 · 510(k) clearance · May 29, 2026
Multimodality Simulation Workspace (MM Sim) (v1.0.0)

Devices with the most adverse event reports

By product code, all years

Ventilator, Non-Continuous (Respirator) (BZD, class 2)299,624
Automated External Defibrillators (Non-Wearable) (MKJ, class 3)118,740
Ventilator, Continuous, Facility Use (CBK, class 2)73,301
Sv70 Ventilator (MNT, class 2)44,521
Interventional Fluoroscopic X-Ray System (OWB, class 2)29,603
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX, class 2)14,405
Ventilator, Continuous, Non-Life-Supporting (MNS, class 2)11,326
Detector And Alarm, Arrhythmia (DSI, class 2)8,595
System, X-Ray, Angiographic (IZI, class 2)6,835

All device makers and procedures · PHG stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to PHG with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	122	8	68,039	301
2025	345	27	94,767	1,273
2024	180	24	97,019	3,333
2023	120	13	54,022	631
2022	51	19	111,232	595
2021	115	10	23,024	376
2020	78	0	18,578	319
2019	97	18	28,429	414
2018	212	1	20,606	323
2017	70	4	20,252	366
2016	107	0	21,025	312
2015	159	0	18,805	211
2014	77	3	16,364	266
2013	51	1	13,230	263
2012	78	2	9,553	291

Newest recalls

Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6.
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions:
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Mode
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6
Class not published · Aug 28, 2026 · When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion direction