--- title: "Philips North America Llc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Philips North America Llc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/philips-north-america-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Philips North America Llc recall records **256** reported ongoing 261 records in this archive. Latest source date Aug 7, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 7, 2026 FDA device enforcement ### [Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.](https://isitonrecall.com/recall/fda-device-z-3040-2026-philips-brilliance-models-brilliance-ict-brilliance-ict-upgrades-brilliance-ict-sp-software-4-1-10-x/) Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Class II Reported ongoing Distribution: US and US Territories. [Official source for Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3040-2026%22) Aug 7, 2026 FDA device enforcement ### [Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x](https://isitonrecall.com/recall/fda-device-z-3041-2026-philips-iqon-spectral-ct-product-codes-iqon-spectral-ct-728332-iqon-spectral-ct-728331-software-4-7/) Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Class II Reported ongoing Distribution: US and US Territories. [Official source for Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3041-2026%22) Aug 7, 2026 FDA device enforcement ### [Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x](https://isitonrecall.com/recall/fda-device-z-3042-2026-philips-ingenuity-ct-product-codes-ingenuity-ct-upgrades-728327-ingenuity-ct-china-728324-ingenuity/) Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Class II Reported ongoing Distribution: US and US Territories. [Official source for Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Inge...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3042-2026%22) Aug 7, 2026 FDA device enforcement ### [Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x](https://isitonrecall.com/recall/fda-device-z-3043-2026-philips-brilliance-ct-64-brilliance-ct-64-channel-product-code-728231-brilliance-ct-64-upgrades-prod/) Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Class II Reported ongoing Distribution: US and US Territories. [Official source for Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrade...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3043-2026%22) Jul 1, 2026 FDA device enforcement ### [Cardiac Workstation 5000. Product Number: 860439.](https://isitonrecall.com/recall/fda-device-z-2955-2026-cardiac-workstation-5000-product-number-860439/) Device will intermittently provide inaccurate data related to native heart rate. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, G... [Official source for Cardiac Workstation 5000. Product Number: 860439.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2955-2026%22) Jul 1, 2026 FDA device enforcement ### [Cardiac Workstation 7000. Product Number: 860441.](https://isitonrecall.com/recall/fda-device-z-2956-2026-cardiac-workstation-7000-product-number-860441/) Device will intermittently provide inaccurate data related to native heart rate. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, G... [Official source for Cardiac Workstation 7000. Product Number: 860441.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2956-2026%22) Jun 5, 2026 FDA device enforcement ### [Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GH...](https://isitonrecall.com/recall/fda-device-z-2579-2026-philips-telemetry-monitor-5500-1-4-ghz-model-number-867232-includes-the-following-system-description/) Potential for device reset to default "NEW\_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN. [Official source for Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descr...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2579-2026%22) May 26, 2026 FDA device enforcement ### [Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A](https://isitonrecall.com/recall/fda-device-z-2522-2026-philips-avalon-fetal-monitor-fm20-part-number-m2702a-part-m2703a/) Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, L... [Official source for Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2522-2026%22) May 26, 2026 FDA device enforcement ### [Philips Avalon Fetal Monitor, FM 30 Part numberM2703A](https://isitonrecall.com/recall/fda-device-z-2523-2026-philips-avalon-fetal-monitor-fm-30-part-numberm2703a/) Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, L... [Official source for Philips Avalon Fetal Monitor, FM 30 Part numberM2703A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2523-2026%22) May 1, 2026 FDA device enforcement ### [DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.](https://isitonrecall.com/recall/fda-device-z-2354-2026-digitaldiagnost-c90-flex-value-chest-er-model-number-712035/) System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. Class II Reported ongoing Distribution: US distribution to California. [Official source for DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2354-2026%22) Jan 7, 2026 FDA device enforcement ### [Brilliance iCT; Product Code (REF): 728306;](https://isitonrecall.com/recall/fda-device-z-1315-2026-brilliance-ict-product-code-ref-728306/) As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr... [Official source for Brilliance iCT; Product Code (REF): 728306;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1315-2026%22) Jan 7, 2026 FDA device enforcement ### [IQon Spectral CT; Product Code (REF): 728332;](https://isitonrecall.com/recall/fda-device-z-1316-2026-iqon-spectral-ct-product-code-ref-728332/) As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr... [Official source for IQon Spectral CT; Product Code (REF): 728332;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1316-2026%22) Jan 7, 2026 FDA device enforcement ### [Spectral CT; Product Code (REF): 728333;](https://isitonrecall.com/recall/fda-device-z-1317-2026-spectral-ct-product-code-ref-728333/) As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr... [Official source for Spectral CT; Product Code (REF): 728333;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1317-2026%22) Jan 7, 2026 FDA device enforcement ### [Spectral CT 7500 on Rails; Product Code (REF): 728334;](https://isitonrecall.com/recall/fda-device-z-1318-2026-spectral-ct-7500-on-rails-product-code-ref-728334/) As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr... [Official source for Spectral CT 7500 on Rails; Product Code (REF): 728334;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1318-2026%22) Dec 12, 2025 FDA device enforcement ### [Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.](https://isitonrecall.com/recall/fda-device-z-1033-2026-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 moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1033-2026%22) Oct 31, 2025 FDA device enforcement ### [IntelliVue MP2. Product Number: M8102A.](https://isitonrecall.com/recall/fda-device-z-0849-2026-intellivue-mp2-product-number-m8102a/) Potential issue where the IntelliVue monitors did not alarm. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh... [Official source for IntelliVue MP2. Product Number: M8102A.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0849-2026%22) Oct 31, 2025 FDA device enforcement ### [IntelliVue MP5. Product Number: M8105A.](https://isitonrecall.com/recall/fda-device-z-0850-2026-intellivue-mp5-product-number-m8105a/) Potential issue where the IntelliVue monitors did not alarm. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh... [Official source for IntelliVue MP5. Product Number: M8105A.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0850-2026%22) Oct 31, 2025 FDA device enforcement ### [IntelliVue MP20. Product Number: M8001A.](https://isitonrecall.com/recall/fda-device-z-0851-2026-intellivue-mp20-product-number-m8001a/) Potential issue where the IntelliVue monitors did not alarm. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh... [Official source for IntelliVue MP20. Product Number: M8001A.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0851-2026%22) Oct 31, 2025 FDA device enforcement ### [IntelliVue MP30. Product Number: M8002A.](https://isitonrecall.com/recall/fda-device-z-0852-2026-intellivue-mp30-product-number-m8002a/) Potential issue where the IntelliVue monitors did not alarm. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh... [Official source for IntelliVue MP30. Product Number: M8002A.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0852-2026%22) Oct 31, 2025 FDA device enforcement ### [IntelliVue MP40. Product Number: M8003A.](https://isitonrecall.com/recall/fda-device-z-0853-2026-intellivue-mp40-product-number-m8003a/) Potential issue where the IntelliVue monitors did not alarm. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh... [Official source for IntelliVue MP40. Product Number: M8003A.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0853-2026%22) ## Reasons in these listed records - Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. - Device will intermittently provide inaccurate data related to native heart rate. - Potential for device reset to default "NEW\_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. - Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. These examples come from this result page and are not a ranking of every recall reason. ## Checking Philips North America Llc ### Is there a recall on philips north america llc right now? This archive contains 261 records, including 256 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Philips North America Llc](https://isitonrecall.com/check/?q=Philips%20North%20America%20Llc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)