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 |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
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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