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Philips North America Recalls
530 recalls on record · April 5, 2017 to July 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 4, 2026Medical DevicesFDA
Philips North America recalls MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
February 4, 2026Medical DevicesFDA
Philips North America recalls Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
January 28, 2026Medical DevicesFDA
Philips North America recalls Patient Information Center iX; Software Version Number: 4.5.0
Hazard: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
January 14, 2026Medical DevicesFDA
Philips North America Llc recalls Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Hazard: 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.
December 17, 2025Medical DevicesFDA
Philips North America recalls Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Hazard: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Hazard: 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.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Hazard: 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.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX850. Product Number: 866470.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX800. Product Number: 865240.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX750. Product Number: 866471.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX700. Product Number: 865241.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX600. Product Number: 865242.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX550. Product Number: 866066.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX500. Product Number: 866064.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX450. Product Number: 866062.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Product Number: 866060.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX100. Product Number: 867033.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP80. Product Number: M8008A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP70. Product Number: M8007A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.