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.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-10-01FDA-DeviceClass IIPhilips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- 2025-07-02FDA-DeviceClass IISpectral CT. Computed tomography X-ray system.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
- 2025-05-28FDA-DeviceClass IIProduct Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia 3.0T CX; Model Number: 781271;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia 1.5T CX; Model Number: 781262;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia 1.5T S; Model Number: 781347;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: Upgrade to MR 7700; Model Number: 782130;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: SmartPath to dStream for 3.0T; Model Number: 782145
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DeviceClass IIProduct Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-14FDA-DeviceClass IIMicrostream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , F
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
- 2025-04-30FDA-DeviceClass IIPhilips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
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