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 |
|---|---|---|---|
| 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 |
| Oct 29, 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | If the screws of tube heat exchanger on the rotating scanner are not tightene... | Class II |
| Oct 29, 2025 | CT 5300; Software Version Number: 4.5, 5.0, 5.1; | If the screws of tube heat exchanger on the rotating scanner are not tightene... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... | The patient support table (couch) may descend unexpectedly to the lowermost p... | Class II |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues th... | Class II |
| May 13, 2025 | Product Name: Upgrade to MR 7700; Model Number: 782130; | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ... | Potential for alignment errors in the cross reference line functionality when... | Class II |
| May 13, 2025 | Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)... | Potential for alignment errors in the cross reference line functionality when... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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