Philips North America Llc: Medical Device Recalls in 2025
Updated on March 25, 2026.
According to to data from the FDA, there were 65 medical device recalls made by Philips North America Llc in 2025. See the details of the recalls below.
You can see similar recalls for other firms.
Data Source: FDA.
- IntelliVue MP30. Product Number: M8002A.
- IntelliVue MP90. Product Number: M8010A.
- IntelliVue Patient Monitor MX800. Product Number: 865240.
- IntelliVue Patient Monitor MX700. Product Number: 865241.
- IntelliVue MP50. Product Number: M8004A.
- IntelliVue Patient Monitor MX100. Product Number: 867033.
- IntelliVue MP2. Product Number: M8102A.
- IntelliVue MP5. Product Number: M8105A.
- CT 5300; Software Version Number: 4.5, 5.0, 5.1;
- IntelliVue Multi-Measurement Module X3. Product Number: 867030.
- Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- IntelliVue Patient Monitor MX550. Product Number: 866066.
- IntelliVue MP70. Product Number: M8007A.
- IntelliVue Patient Monitor MX850. Product Number: 866470.
- IntelliVue Patient Monitor MX500. Product Number: 866064.
- IntelliVue Multi Measurement Server X2. Product Number: M3002A.
- IntelliVue MP80. Product Number: M8008A.
- IntelliVue Patient Monitor MX600. Product Number: 865242.
- IntelliVue MP20. Product Number: M8001A.
- IntelliVue Patient Monitor MX750. Product Number: 866471.
- IntelliVue MP40. Product Number: M8003A.
- IntelliVue MP60. Product Number: M8005A.
- IntelliVue Patient Monitor MX400. Product Number: 866060.
- IntelliVue Patient Monitor MX450. Product Number: 866062.
- Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
- Philips 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.
- Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
- Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
- Philips 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.
- Philips 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.
- Philips 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
- Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
- Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
- Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
- Spectral CT. Computed tomography X-ray system.
- Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
- Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
- Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
- Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
- Product Name: Ingenia 1.5T S; Model Number: 781347;
- Product Name: Upgrade to MR 7700; Model Number: 782130;
- Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
- Product Name: Ingenia 1.5T CX; Model Number: 781262;
- Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
- Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
- Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
- Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
- Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
- Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
- Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
- Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
- Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- IntelliVue Patient Monitor MX500. Model Number: 866064
- Product Name: Ingenia 3.0T CX; Model Number: 781271;
- Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
- Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
- Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
- Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
- Microstream 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 , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.
- IntelliBridge EC10 Module. Model Number: 865115
- IntelliVue Patient Monitor MX450. Model Number: 866062
- IntelliVue Patient Monitor MX400. Model Number: 866060
- Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
- IntelliVue Patient Monitor MX550. Model Number: 866066
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