Philips North America Llc
65 federal recalls on file. 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.
- 2026-02-18FDA-DeviceClass IISpectral 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.
- 2026-02-18FDA-DeviceClass IISpectral 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.
- 2026-02-18FDA-DeviceClass IIIQon 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.
- 2026-02-18FDA-DeviceClass IIBrilliance 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.
- 2026-01-14FDA-DeviceClass IIPhilips 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.
- 2025-12-10FDA-DeviceClass IICT 5300; 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.
- 2025-12-10FDA-DeviceClass IIIncisive 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.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Patient Monitor MX100. Product Number: 867033.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Multi-Measurement Module X3. Product Number: 867030.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue Multi Measurement Server X2. Product Number: M3002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP80. Product Number: M8008A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceClass IIIntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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