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Philips Respironics, Inc.

Philips Respironics, Inc. Recalls

All product recalls associated with Philips Respironics, Inc..

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Recall Summary

Total Recalls

1000

Past Year

272

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 641–660 of 1137 recalls

Philips Respironics, Inc.: Trilogy Evo Universal, Product number DS2000X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE21...

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, E...

1...31 323334 35...57

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FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Ultrasound Inc: EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ...

Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.

FDAJul 22, 2021Nationwide• Philips Ultrasound Inc

Philips North America LLC: Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE,...

Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

FDAJul 16, 2021Nationwide• Philips North America LLC

Philips North America: (1) Ingenia Ambition X (Product Number 781356); (2) Ingen...

The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

FDAJul 15, 2021CA, DE, FL +21 more• Philips North America

Philips Respironics, Inc.: SystemOne (Q-Series), DreamStation, DreamStation Go, Dor...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Co...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4,...

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips Respironics E30 with Humidifier, Continuous Venti...

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventil...

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series ...

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.

Philips North America Llc: 728333 Spectral CT 7500 -Computed Tomography X-ray system

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

FDAJun 8, 2021Nationwide• Philips North America Llc

Philips North America Llc: 728306 Brilliance iCT-Computed Tomography X-ray systems 7...

FDAJun 8, 2021Nationwide• Philips North America Llc

Philips North America Llc: 728332 IQon Spectral CT-Computed Tomography X-ray system

FDAJun 8, 2021Nationwide• Philips North America Llc

Philips North America Llc: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray sy...

FDAJun 8, 2021Nationwide• Philips North America Llc

Philips North America Llc: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Com...

FDAJun 8, 2021Nationwide• Philips North America Llc

Philips Healthcare: Azurion systems with software release R2.0.x

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

FDAMay 26, 2021Nationwide• Philips Healthcare

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: Azurion systems with software release R1.x

In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

FDAMay 26, 2021Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: DigitalDiagnost 4 Flex / Value. radiography and fluorosc...

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany