Philips North America Llc recalls
Every recall we track for Philips North America Llc — 422 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 31 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Philips North America Llc peaked in 2024 (118); 422 since 2017. 7% rated “stop using now”.
All FDA recall records for Philips North America Llc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 0 | 0 | 1 |
| 2018 | 0 | 2 | 0 | 0 | 2 |
| 2019 | 5 | 22 | 23 | 1 | 51 |
| 2020 | 0 | 18 | 16 | 3 | 37 |
| 2021 | 9 | 43 | 16 | 4 | 72 |
| 2022 | 3 | 5 | 7 | 1 | 16 |
| 2023 | 6 | 21 | 5 | 0 | 32 |
| 2024 | 7 | 95 | 11 | 5 | 118 |
| 2025 | 0 | 44 | 21 | 1 | 66 |
| 2026 (to date) | 0 | 5 | 11 | 11 | 27 |
Most common reasons for Philips North America Llc recalls
What to do if you have a recalled Philips North America Llc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Philips North America Llc recalls
60 shown- Lower riskMedical device
Philips North America Llc recalls Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Philips recalls Achieva 3.0T MRI scanners with specific model numbers due to a software issue that can terminate scans during image reconstruction if scan parameters are manually adjusted.
PhilipsAug 21, 2026 - Lower riskMedical device
Philips North America Llc recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Philips recalls 62 units of Spectral CT 7500 scanners with software V5.2.x due to potential extra radiation exposure from bolus tracking errors. Affected units sold in U.S. and territories.
PhilipsAug 18, 2026 - Lower riskMedical device
Philips North America Llc recalls Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code:
Philips recalls specific models of Brilliance CT 64 scanners due to potential radiation performance issues that could affect equipment safety. Affected units include Channel Product Code 728231 and Upgrades Product Code 728232.
PhilipsAug 7, 2026 - Lower riskMedical device
Philips North America Llc recalls Cardiac Workstation 5000. Product Number: 860439.
Philips recalls Cardiac Workstation 5000 (product number 860439) due to potential inaccurate native heart rate data. Affected units include specific serial numbers listed in the recall.
PhilipsJul 1, 2026 - Lower riskMedical device
Philips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor
Philips recalls Telemetry Monitor 5500 1.4 GHz (model 867232) due to potential reset to default state causing loss of configuration and failure to reconnect to central monitoring system.
PhilipsJun 5, 2026 - Lower riskMedical device
Philips North America Llc recalls Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips recalls Avalon Fetal Monitors (FM20) with part numbers M2702A and M2703A due to incorrect speaker connector assembly that may cause intermittent or permanent loss of speaker output.
PhilipsMay 26, 2026 - Use cautionMedical device
Philips North America Llc recalls DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Philips recalls DigitalDiagnost C90 Flex/Value/Chest/ER models 712035 without seismic kit for wall stands, risking instability during earthquakes.
PhilipsMay 1, 2026 - Use cautionMedical device
Philips North America Llc recalls Brilliance iCT; Product Code (REF): 728306;
Philips recalls Brilliance iCT CT scanners with specific serial numbers due to potential unsecured rotor parts that could be expelled during operation. Affected units may need repair or replacement.
PhilipsJan 7, 2026 - Lower riskMedical device
Philips North America Llc recalls Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Philips recalls Smart-hopping 2.0 AP 1.4 GHz Patient Monitors with specific serial numbers due to potential signal disconnection when moving between access points with rapid signal strength changes.
PhilipsDec 12, 2025 - Use cautionMedical device
Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.
Philips recalls IntelliVue MP90 monitors (product number M801: M8010A) due to potential failure to alarm. Affected units may not alert users to critical health changes.
PhilipsOct 31, 2025 - Use cautionMedical device
Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Philips recalls CT 5300 scanners with software versions 4.5, 5.0, and 5.1 due to potential tube heat exchanger detachment causing damage. Affected units have specific serial numbers and model numbers.
PhilipsOct 29, 2025 - Use cautionMedical device
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Philips recalls Brilliance iCT CT systems with model 728306 due to risk of patient support table descending unexpectedly after component replacement.
PhilipsAug 13, 2025 - Use cautionMedical device
Philips North America Llc recalls Spectral CT. Computed tomography X-ray system.
Philips recalls Spectral CT X-ray systems with affected software that may cause motion issues leading to contact with operator or patient. Affected units have specific part and serial numbers listed in the recall.
PhilipsMay 29, 2025 - Lower riskMedical device
Philips North America Llc recalls Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Philips recalls Evolution Upgrade 3.0T MRI systems with model numbers 782117 and 782143 due to potential alignment errors in cross reference line functionality when using MobiView app.
PhilipsMay 13, 2025 - Use cautionMedical device
Philips North America Llc recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi
Philips recalls neonatal and infant intubation CO2 filter lines due to potential difficulty disconnecting adapters from endotracheal tubes. Affected models include specific part numbers and system codes.
PhilipsApr 7, 2025 - UnratedMedical device
Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Philips recalls CT scanners with software version 4.8.0.10430 due to unintended motion that may cause collisions with patients or operators. Affected models include specific serial numbers and UDI codes. No remedy is listed in the recall notice.
PhilipsApr 1, 2025 - Use cautionMedical device
Philips North America Llc recalls Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Philips recalls DXR System and DuraDiagnost Rel. 4 X-Ray systems with potential collimator fall risk due to incorrect installation. Affected units include specific serial numbers.
PhilipsMar 10, 2025 - Use cautionMedical device
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic,
Philips recalls Zenition 70 medical devices due to wireless foot switch potentially getting stuck, causing unintended radiation emissions during procedures. Affected units have specific product codes and serial numbers.
PhilipsFeb 25, 2025 - Use cautionMedical device
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Philips recalls IntelliVue MX400 patient monitors with model 866060 due to potential failure to alarm when a Hamilton ventilator disconnects from the EC10 Module or IntelliBridge I/O board.
PhilipsJan 15, 2025 - Lower riskMedical device
Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Philips recalls Smart-Hopping 2.0 AP 1.4 GHz (Model 867216) due to network disconnections, data loss, and frequent 'Loss of AP' alerts. All software versions affected.
PhilipsNov 20, 2024 - Use cautionMedical device
Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Philips recalls Spectral CT and Spectral CT Plus models 728333, 728340, 728344 due to potential collision with operator or misdiagnosis risks during medical procedures.
PhilipsNov 16, 2024 - Use cautionMedical device
Philips North America Llc recalls dS Breast 16ch 1.5T
Philips recalls certain dS Breast 16ch 1.5T MRI scanners due to potential patient harm during scans. Affected units have specific serial numbers and reference codes listed in the recall notice.
PhilipsNov 4, 2024 - Use cautionMedical device
Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of
Philips recalls Ingenia 3.0T MRI machines with loose RF carrier screws that could block patient movement, causing delays in diagnosis or anxiety. Affected units have specific serial numbers.
PhilipsSep 3, 2024 - Lower riskMedical device
Philips North America Llc recalls IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated
Philips recalls IntelliVue Patient Monitors MX500 with L.x and M.x software versions that may not offer certain features due to incorrect entitlements, risking incorrect patient treatment.
PhilipsJun 28, 2024 - Use cautionMedical device
Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva
Philips recalls SENSE XL TORSO COIL 1.5T 16-element coils for torso/abdomen MRI. Coils may overheat and cause burns during scans. Affected models include specific serial numbers and kit numbers.
PhilipsJun 5, 2024 - Lower riskMedical device
Philips North America Llc recalls Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal
Philips recalls Avalon Ultrasound Transducers with model 867246 that may give inaccurate fetal heart rate readings during multiple pregnancies. Affected units have specific serial numbers; contact Philips for details.
PhilipsMay 22, 2024 - Use cautionMedical device
Philips North America Llc recalls HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system,
Philips recalls HA FlexTrak II patient transport trolleys with serial numbers starting from 100018 to 100734. Oil leaks when pressing hydraulic pedal may cause slipping or falling hazards. Affected units should be checked for serial numbers listed.
PhilipsMay 3, 2024 - Use cautionMedical device
Philips North America Llc recalls Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Philips recalls certain Achieva 3.0T MRI scanners due to a potential loose connection that could cause smoke or fire alarms in hospital technical rooms. Affected models include serial numbers starting with 24079 and specific model numbers.
PhilipsMay 3, 2024 - Use cautionMedical device
Philips North America Llc recalls Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for
Philips recalls Ingenia 1.5T MRI systems with Evolution Upgrade software R5.7.1 that may not warn of low ventilation settings, potentially causing overheating or burning sensations. Affected units have specific serial numbers.
PhilipsApr 22, 2024 - Lower riskMedical device
Philips North America Llc recalls Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Philips recalls Patient Information Center iX and iX Expand software version 4.x due to Event Catalog information not saving when copied between units. Affected units have specific serial numbers.
PhilipsApr 19, 2024 - Use cautionMedical device
Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number:
Philips recalls specific models of Incisive CT computed tomography systems due to a metal mounting box that may become compromised, potentially expelling fragments during rotation. Affected units include model 728144 with listed serial numbers.
PhilipsApr 15, 2024 - Use cautionMedical device
Philips North America Llc recalls The Oncology Essentials Package of the Spectral CT imaging system.
Philips recalls its Spectral CT imaging system (model 728333) due to potential laser reflection causing misdiagnosis. Affected units have specific serial numbers. Contact Philips for details.
PhilipsMar 29, 2024 - Use cautionMedical device
Philips North America Llc recalls Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT
Philips recalls specific APC UPS units for PIC iX systems that may shut down during patient monitoring, causing delays in detecting patient condition changes. Affected units have serial numbers with date codes prior to certain values.
PhilipsMar 22, 2024 - Use cautionMedical device
Philips North America Llc recalls Ingenia 1.5T S, Magnetic Resonance System.
Philips recalls Ingenia 1.5T S MRI systems with potentially incorrectly installed patient support table floor plates. Affected units have specific serial numbers; contact Philips for details.
PhilipsMar 12, 2024 - Use cautionMedical device
Philips North America Llc recalls DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model:
Philips recalls DIVA 24-inch LCD touch displays used with PIC iX system that may generate false alarms, potentially delaying critical patient condition detection. Affected units have specific serial numbers.
PhilipsFeb 15, 2024 - Lower riskMedical device
Philips North America Llc recalls Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Philips recalls Spectral CT 7500 X-ray systems with software version 5.0.0.X due to multiple software issues affecting device functionality. Affected units have specific model and serial numbers listed in the recall notice.
PhilipsNov 30, 2023 - Stop using nowMedical device
Philips North America Llc recalls Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR)
Philips recalls Panorama 1.0T HFO MRI systems (model 781250/781350) due to helium gas buildup risks. If the system fails to contain helium, it could cause injury or death from chemical exposure, debris, or asphyxia.
PhilipsNov 17, 2023 - Stop using nowMedical device
Philips North America Llc recalls SmartPath to dStream for 1.5T
Philips recalls SmartPath to dStream 1.5T MRI machines with serial numbers 5447-32798 due to potential smoke/fire from Gradient Coil component failure. No remedy specified.
PhilipsOct 23, 2023 - Use cautionMedical device
Philips North America Llc recalls Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation
Philips recalls Brilliance CT Big Bore scanners with software version V4.8.0.10421 (model 728244) due to potential incorrect radiation therapy planning causing cancer growth. Affected units may require software update.
PhilipsOct 9, 2023 - Use cautionMedical device
Philips North America Llc recalls DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Philips recalls DigitalDiagnost 4 Chest/Emergency X-ray systems that may fail and fall from ceilings, posing a fall hazard. Affected units have specific serial numbers and model numbers.
PhilipsSep 21, 2023 - Use cautionMedical device
Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa)
Philips recalls EarlyVue VS30 Vitals Monitors with specific serial numbers due to a software issue that may prevent alarms when respiration rates are outside safe limits. Affected units should be checked for serial numbers listed.
PhilipsAug 31, 2023 - Use cautionMedical device
Philips North America Llc recalls Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX
Philips recalls Patient Information Center iX devices with software version 4.x due to potential blank screen causing delayed patient monitoring. Affected units may require manual reboot.
PhilipsAug 17, 2023 - Lower riskMedical device
Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are
Philips recalls IntelliVue Patient Monitors MX400/MX450/MX500/MX550 with software version P.01.01 and Option CP2 that may not have enhanced arrhythmia detection features enabled due to factory configuration errors.
PhilipsJun 14, 2023 - Lower riskMedical device
Philips North America Llc recalls DigitalDiagnost C90, Model No. 712034 and 712035
Philips recalls DigitalDiagnost C90 models 712034 and 712035 due to a software login issue that may prevent user access. Affected units include specific serial numbers and UDI-DI codes.
PhilipsMay 19, 2023 - Use cautionMedical device
Philips North America Llc recalls Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Philips recalls Spectral CT 7500 X-Ray Systems (model 728333) due to risk of foot entrapment during operation, potentially causing injury. Affected units have specific serial numbers listed in the recall notice.
PhilipsMar 17, 2023 - Use cautionMedical device
Philips North America Llc recalls Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Philips recalls DigitalDiagnost C50 X-ray machines (model 712201) due to potential ceiling suspension drop if annual PM for telescopic carriage isn't performed, risking patient and user injuries.
PhilipsMar 9, 2023 - Lower riskMedical device
Philips North America Llc recalls EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Philips recalls EarlyVue VS30 Vital Signs Monitors with software versions A.00.01 and A.00.02 due to missing calibration alarm that could cause inaccurate CO2 readings, potentially missing patient health changes.
PhilipsMar 6, 2023 - Stop using nowMedical device
Philips North America Llc recalls Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Philips recalls specific MRI systems due to gradient coil heat risk. Affected models may produce smoke/fire. No remedy provided in official notice.
PhilipsNov 22, 2022 - Stop using nowMedical device
Philips North America Llc recalls Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN:
Philips recalls fetal heart rate monitoring electrodes (PN: 989803137631) due to spiral tip breaking off during use, requiring surgical removal from newborns. Affected units shipped between May 2020 and November 2022.
PhilipsNov 21, 2022 - Use cautionMedical device
Philips North America Llc recalls Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general
Philips recalls ProxiDiagnost N90 1.0 and 1.1 models with potential tabletop cable cracks that could prevent table tilting or braking. Affected units have specific serial numbers; stop use if table movement fails.
PhilipsOct 21, 2022 - Lower riskMedical device
Philips North America Llc recalls MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Philips recalls MR Patient Care Portal 5000 desktop units with specific serial numbers due to intermittent audio failure that persists after power cycling.
PhilipsSep 6, 2022 - Lower riskMedical device
Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into
Philips recalls certain CT scanners due to software issues that may cause incorrect image display, error interpreting patient images, and patient exposure to incorrect image/function during clinical use.
PhilipsMar 29, 2022 - Lower riskMedical device
Philips North America Llc recalls DigitalDiagnost C50 1.1
Philips recalls DigitalDiagnost C50 1.1 models due to potential incorrect radiation dose from misaligned imaging. Affected units may show wrong anatomy positions during scans.
PhilipsFeb 25, 2022 - Use cautionMedical device
Philips North America Llc recalls Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and
Philips recalls specific software versions for neonatal blood pressure monitors due to risk of injury from incorrect settings in newborns. Affected units may cause bruising or nerve damage if not set to neonatal mode.
PhilipsFeb 22, 2022 - Lower riskMedical device
Philips North America, LLC recalls The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following
Philips recalls autoclavable temperature probes with model numbers 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641. The recall involves updated cleaning instructions to prevent improper disinfection.
PhilipsFeb 7, 2022 - Lower riskMedical device
Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Philips recalls adult Smart Pads cartridges for HEARSTART HS1 defibrillators due to potential gel separation that could reduce pad effectiveness. Affected units sold since 2:00 PM on 2023-08-01.
PhilipsFeb 4, 2022 - Lower riskMedical device
Philips North America Llc recalls Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model
Philips recalls specific Allura and Azurion models with StentBoost Live R2.0 software that may show incorrect X-ray images from previous runs instead of current patient scans.
PhilipsFeb 2, 2022 - UnratedMedical device
Philips North America Llc recalls eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1,
Philips recalls specific versions of eCareManager software for in-hospital patient care. The unapproved software may not be safe for medical use. Affected units include model 865325 with listed software versions.
PhilipsJan 3, 2022 - Lower riskMedical device
Philips North America Llc recalls Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips recalls all Medichoice Infant Heel Warmers due to FDA labeling changes needed for 510(k) clearance. Affected units require new regulatory approval before safe use.
PhilipsNov 29, 2021 - UnratedMedical device
Philips North America Llc recalls Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Philips recalls all Infa-Therm Transport Mattresses with reference number 989805616831 1015 due to FDA labeling changes needed for 510(k) clearance. No action is required as the devices are not yet legally sold.
PhilipsNov 26, 2021
Philips North America Llc recall questions
How many recalls has Philips North America Llc had?
422 recalls from Philips North America Llc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Philips North America Llc recall?
Philips North America Llc recalls Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;, dated Aug 21, 2026. Every Philips North America Llc recall is listed on this page, newest first.
Why are Philips North America Llc products recalled?
The most common reasons on record: Patient support table floor plate may be incorrectly installed. (41); Potential issue where the IntelliVue monitors did not alarm. (22); Potential for units suspended on the ceiling to fail and fall. (10); Potential for coils to heat up and harm patients (burn). (3).
What should I do if I have a recalled Philips North America Llc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Philips North America Llc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.