Philips North America LLC

Reports per year

Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Automated External Defibrillators (Non-Wearable)MKJ17,298
• Detector And Alarm, ArrhythmiaDSI1,267
• Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX861
• Over-The-Counter Automated External DefibrillatorNSA793
• Ventilator, Non-Continuous (Respirator)BZD524
• Electrode, Circular (Spiral), Scalp And ApplicatorHGP47
• System, Imaging, Pulsed Doppler, UltrasonicIYN42
• Alarm, Blood-PressureDSJ34
• System, Measurement, Blood-Pressure, Non-InvasiveDXN34
• ElectrocardiographDPS19

Recent recalls

• 2026-06-24Open, ClassifiedSoftware design

  Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

  Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

• 2026-06-22Open, ClassifiedProcess control

  Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

• 2026-06-22Open, ClassifiedProcess control

  Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

• 2026-06-05Open, ClassifiedDevice Design

  DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

  System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

• 2026-02-06Open, ClassifiedProcess change control

  Brilliance iCT; Product Code (REF): 728306;

  As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

• 2026-02-06Open, ClassifiedProcess change control

  IQon Spectral CT; Product Code (REF): 728332;

  As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

• 2026-02-06Open, ClassifiedProcess change control

  Spectral CT; Product Code (REF): 728333;

  As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

• 2026-02-06Open, ClassifiedProcess change control

  Spectral CT 7500 on Rails; Product Code (REF): 728334;

  As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

• 2026-01-08Open, ClassifiedSoftware design

  Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

  It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

• 2025-12-03Open, ClassifiedUnder Investigation by firm

  Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

  If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.