Philips North America Llc

Complete recall history across all FDA and CPSC categories, 312 total recalls

Philips North America Llc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (312)

FDA medical device enforcement actions by Philips North America Llc. Showing most recent 50.

Date Product Reason Class
Aug 21, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 MR 5300 Model Number (REF): 1. 782110, 2. 782152; A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... A software issue will terminate an examination during the image reconstructio... Class II
Aug 21, 2026 Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... A software issue will terminate an examination during the image reconstructio... Class II
Aug 18, 2026 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... The Bolus tracking scan application may crash with a system error message. Bo... Class II
Aug 7, 2026 Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... Philips has identified an unintended radiation issue with the Philips IQon, i... Class II
Aug 7, 2026 Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... Philips has identified an unintended radiation issue with the Philips IQon, i... Class II
Aug 7, 2026 Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... Philips has identified an unintended radiation issue with the Philips IQon, i... Class II
Aug 7, 2026 Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... Philips has identified an unintended radiation issue with the Philips IQon, i... Class II
Jul 1, 2026 Cardiac Workstation 7000. Product Number: 860441. Device will intermittently provide inaccurate data related to native heart rate. Class II
Jul 1, 2026 Cardiac Workstation 5000. Product Number: 860439. Device will intermittently provide inaccurate data related to native heart rate. Class II
Jun 5, 2026 Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... Potential for device reset to default "NEW_DEVICE" state, which may lead to a... Class II
May 26, 2026 Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Monitor has incorrect assembly of the speaker connector which can cause devic... Class II
May 26, 2026 Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Monitor has incorrect assembly of the speaker connector which can cause devic... Class II
May 1, 2026 DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. System was delivered without the required Seismic kit for Wall Stand VS2, whi... Class II
Jan 7, 2026 Spectral CT 7500 on Rails; Product Code (REF): 728334; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to... Class II
Jan 7, 2026 IQon Spectral CT; Product Code (REF): 728332; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to... Class II
Jan 7, 2026 Spectral CT; Product Code (REF): 728333; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to... Class II
Jan 7, 2026 Brilliance iCT; Product Code (REF): 728306; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to... Class II
Dec 12, 2025 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 movi... Class II
Oct 31, 2025 IntelliVue MP70. Product Number: M8007A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX450. Product Number: 866062. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX750. Product Number: 866471. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX550. Product Number: 866066. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Multi-Measurement Module X3. Product Number: 867030. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX400. Product Number: 866060. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX600. Product Number: 865242. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP20. Product Number: M8001A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP5. Product Number: M8105A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP60. Product Number: M8005A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Multi Measurement Server X2. Product Number: M3002A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP40. Product Number: M8003A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX100. Product Number: 867033. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP80. Product Number: M8008A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP50. Product Number: M8004A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP2. Product Number: M8102A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX850. Product Number: 866470. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX500. Product Number: 866064. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX700. Product Number: 865241. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue Patient Monitor MX800. Product Number: 865240. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP30. Product Number: M8002A. Potential issue where the IntelliVue monitors did not alarm. Class II
Oct 31, 2025 IntelliVue MP90. Product Number: M8010A. Potential issue where the IntelliVue monitors did not alarm. Class II

View all 312 device recalls →

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The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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