Philips North America Llc
437 federal recalls on file, showing the 162 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips North America Llc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IICheck your Philips Allura Xper FD20/20 OR Table
Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/20 OR Tables where X-ray imaging may not start or may work intermittently. Five units have been affected outside the United States. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IICheck your Philips Allura Xper FD20/20 X-ray system
Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work only intermittently, which could affect clinical procedures.
- 2026-04-08FDA-DeviceClass IICheck your Philips Allura Xper X-ray system
Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/10 X-ray systems that may prevent imaging from starting or cause it to work intermittently. This affects 85 systems worldwide, including 20 in the United States. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIContact Philips about your ALLURA Xper FD10 table
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10 operating room tables where X-ray imaging may not start or may work only intermittently. Two units worldwide are affected. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using Philips ALLURA Xper FD20 foot switch
Philips has found that the wired foot switch on certain ALLURA Xper FD20 operating room tables may fail to start X-ray imaging or may work only intermittently. This affects 4 units worldwide. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using affected Philips ALLURA X-ray tables
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 surgical X-ray tables. The switch may fail to start X-ray imaging or may cause imaging to work only intermittently, which could disrupt surgical procedures. This affects 196 units worldwide.
- 2026-04-08FDA-DeviceClass IIStop using affected Philips ALLURA X-ray systems
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 Biplane X-ray systems where imaging may not start or may work intermittently. This affects 461 units worldwide, including 198 in the US. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IIStop using affected Philips X-ray foot switches
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 X-ray systems where imaging may not start or may start intermittently. This affects specific serial numbers across three system codes. No injuries have been reported.
- 2026-04-08FDA-DeviceClass IICheck your Philips ALLURA Xper system serial number
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10/10 X-ray systems where imaging may not start or may work on and off intermittently. This affects 112 systems distributed worldwide, identified by specific serial numbers.
- 2026-04-08FDA-DeviceClass IIStop using Philips ALLURA Xper FD10 foot switch
Philips has identified a defect in the wired foot switch on certain ALLURA Xper FD10 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This could delay or disrupt imaging procedures. Philips is working with healthcare facilities to resolve the issue.
- 2026-04-08FDA-DeviceClass IICheck your Philips ALLURA X-ray foot switch
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10F X-ray imaging systems. The foot switch may fail to start X-ray imaging or may cause imaging to work intermittently, which could affect clinical procedures. The issue affects 10 systems total, with no injuries reported.
- 2026-04-08FDA-DeviceClass IIContact Philips about Allura Xper FD10C foot switch issue
Philips has identified a problem with the wired foot switch on certain Allura Xper FD10C X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start intermittently, which could affect clinical workflow. This affects a small number of systems worldwide.
- 2026-04-08FDA-DeviceClass ICheck your Philips Respironics ventilator settings
Philips Respironics has recalled certain Trilogy Evo Universal home ventilators (Software Version 1.05.15.00) because the obstruction alarm may not trigger as quickly as safety standards require. In some cases, the alarm could be delayed by up to four breaths, which may prevent timely notification of a breathing tube blockage.
- 2026-04-08FDA-DeviceClass ICheck your Philips Respironics ventilator settings
Philips Respironics has recalled certain Trilogy EV300 home ventilators (software version 1.05.15.00) because the obstruction alarm may not trigger quickly enough if the breathing tube becomes blocked. In rare cases, the alarm could be delayed by up to four breaths, which is longer than safety standards allow.
- 2026-04-08FDA-DeviceClass ICheck your Philips Respironics ventilator settings
Some Philips Respironics Trilogy Evo O2 ventilators with software version 1.05.15.00 may not sound an obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time available to respond to a blockage.
- 2026-04-08FDA-DeviceClass ICheck your Philips Respironics Trilogy Evo ventilator
Some Philips Respironics Trilogy Evo home ventilators with Software Version 1.05.15.00 may not sound their obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time a user has to respond to an airway obstruction.
- 2026-04-01FDA-DeviceClass IIICheck Philips X7-2 transducer labelling for useful life
Philips is clarifying and updating labelling on certain X7-2 ultrasound transducers to better define their useful life in the field. This affects a small number of units distributed nationwide. No injuries have been reported.
- 2026-04-01FDA-DeviceClass IIICheck Philips X3-1 ultrasound transducer labeling
Philips is clarifying labeling on certain X3-1 ultrasound transducers to better define their useful lifespan in clinical use. This affects a small number of devices distributed nationwide. No injuries have been reported.
- 2026-04-01FDA-DeviceClass IIICheck Philips S5-2 ultrasound transducer labeling
Philips Ultrasound, Inc. is providing clarification and updated labeling for the S5-2 Ultrasound Transducer to define its useful life in the field. This affects a limited number of units distributed nationwide.
- 2026-04-01FDA-DeviceClass IIICheck your Philips S4-1 transducer labeling
Philips is recalling certain S4-1 ultrasound transducers to clarify and update labeling that defines how long these devices can be safely used in clinical settings. No injuries have been reported. The recall affects 41 units distributed nationwide.
- 2026-04-01FDA-DeviceClass IIICheck Philips OMNI III TEE transducer expiration
Philips is clarifying and updating labeling on certain OMNI III TEE ultrasound transducers to better define their useful life in the field. This is a precautionary measure affecting 75 units distributed nationwide.
- 2026-04-01FDA-DeviceClass IIICheck Philips OMNI II TEE transducer useful life label
Philips is clarifying the useful life labeling on certain OMNI II TEE Ultrasound Transducers to ensure healthcare facilities have accurate information about when these devices should be replaced. Two units with specific serial numbers (02P8MV and 02MH3J) were affected and distributed nationwide.
- 2026-04-01FDA-DeviceClass IIICheck Philips ultrasound transducer useful life labeling
Philips is clarifying labeling on certain Mini Multi TEE Ultrasound Transducers to better define when these devices should no longer be used in clinical settings. The affected units may lack clear guidance on their useful lifespan, which could affect safe operation.
- 2026-04-01FDA-DeviceClass IIICheck Philips L17-5 ultrasound transducer labeling
Philips is clarifying labeling on certain L17-5 Ultrasound Transducers to better define their useful life in clinical use. This affects 2 units with specific model and serial numbers distributed nationwide. No injuries have been reported.
- 2026-04-01FDA-DeviceClass IIICheck Philips L12-5 ultrasound transducer labeling
Philips is clarifying and updating labeling on certain L12-5 ultrasound transducers to better define their useful life in the field. This affects 40 units distributed nationwide. No injuries have been reported.
- 2026-04-01FDA-DeviceClass IIICheck your Philips C9-4 ultrasound transducer
Philips Ultrasound, Inc. is clarifying labeling on the C9-4 ultrasound transducer to better define how long the device remains safe and effective in clinical use. This affects a very limited number of units distributed nationwide.
- 2026-04-01FDA-DeviceClass IIICheck Philips 3D6-2 transducer useful life labeling
Philips is clarifying and updating labeling on certain 3D6-2 Ultrasound Transducers to better define their useful life in the field. This affects a limited number of units distributed nationwide. No injuries have been reported.
- 2026-04-01FDA-DeviceClass ICheck your Philips Respironics ventilator settings
Philips Respironics has recalled Trilogy Evo Universal ventilators (software version 1.05.15.00) because using certain non-pneumatic nebulizers with these machines may cause a mismatch between the breathing volume set by your doctor and the volume your lungs actually receive. This could affect the effectiveness of your ventilation therapy.
- 2026-04-01FDA-DeviceClass IStop using Philips Respironics Trilogy EV300 with non-pneumatic nebulizers
Philips Respironics has recalled Trilogy EV300 ventilators (software version 1.05.15.00) because using them with certain types of nebulizers can cause the device to deliver a different amount of air to the patient than what was set. This mismatch between the intended and actual breath volume could affect patient safety.
- 2026-04-01FDA-DeviceClass ICheck your Philips Respironics ventilator settings
Philips Respironics has recalled certain Trilogy Evo O2 home ventilators because using non-pneumatic nebulizers with them may cause a mismatch between the breath volume set on the machine and the volume actually delivered to the patient. This discrepancy could result in the patient receiving too much or too little air during ventilation.
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