Data / Medical devices / United States / Philips North America LLC
Philips North America LLC: FDA-registered device maker in Cambridge, MA, United States, 6 510(k) clearances
Philips North America LLC is registered with the FDA (registration 3006648320) in Cambridge, MA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 14, 2022. 35 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006648320
- Address
- 222 Jacobs Street, Cambridge, MA, United States, 02141
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 7, 2022
- Registered through
- 2026
- Brand names listed
- Capsule Surveillance System, Capsule Vitals Plus Patient Monitoring System, SmartLinx Vitals Plus Patient Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2022 | K213335 | Capsule Surveillance System | MWI | Substantially Equivalent | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | accessdata.fda.gov |
| October 19, 2021 | K210204 | Capsule Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie Sas | accessdata.fda.gov |
| April 17, 2019 | K183638 | SmartLinx Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie | accessdata.fda.gov |
| August 8, 2018 | K180734 | SmartLinx Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie | accessdata.fda.gov |
| October 24, 2017 | K171751 | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module | MWI | Substantially Equivalent | Capsule Technologie Sas | accessdata.fda.gov |
| September 17, 2015 | K151071 | SmartLinx Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie Sas | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2026 | 100074 | Not yet classified | Open, Classified | Model Number: 712010. | Potential for the device to fail immediately after an exposure, causing the system to remain stationary. | accessdata.fda.gov |
| September 16, 2026 | 99908 | Class II | Ongoing | Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216 | Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX). | accessdata.fda.gov |
| August 28, 2026 | 99834 | Class II | Ongoing | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13 | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly p | accessdata.fda.gov |
| July 31, 2026 | 99566 | Class II | Ongoing | Philips Patient Information Center iX REF:866389 | Due to software malfunction, patient information system may freeze and become unresponsive. | accessdata.fda.gov |
| April 14, 2026 | 98779 | Class II | Ongoing | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | accessdata.fda.gov |
| December 22, 2025 | 98217 | Class II | Ongoing | Patient Information Center iX; Software Version Number: 4.5.0 | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. | accessdata.fda.gov |
| December 3, 2025 | 98111 | Class II | Ongoing | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | accessdata.fda.gov |
| October 27, 2025 | 98052 | Class II | Ongoing | Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications. | accessdata.fda.gov |
| September 12, 2025 | 97612 | Class II | Ongoing | Cardiac Workstation 5000; Model Number: 860439 | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. | accessdata.fda.gov |
| June 30, 2025 | 97172 | Class II | Ongoing | Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345 | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | accessdata.fda.gov |
| May 29, 2025 | 96999 | Class II | Ongoing | Achieva XR Product Numbers: (1) 781153, (2) 781253 | identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could | accessdata.fda.gov |
| August 30, 2024 | 95295 | Class II | Ongoing | IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066) | During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission. | accessdata.fda.gov |
| February 28, 2024 | 94185 | Class II | Ongoing | Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. | accessdata.fda.gov |
| January 3, 2024 | 93787 | Class II | Ongoing | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury. | accessdata.fda.gov |
| December 29, 2023 | 93788 | Class III | Ongoing | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel. | accessdata.fda.gov |
| December 15, 2023 | 93773 | Class II | Ongoing | ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vul | accessdata.fda.gov |
| December 15, 2023 | 93767 | Class I | Ongoing | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A | Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal | accessdata.fda.gov |
| December 7, 2023 | 93654 | Class II | Ongoing | Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 | If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency. | accessdata.fda.gov |
| November 30, 2023 | 93643 | Class II | Ongoing | BrightView, Gamma Camera System, Product Code 882480. | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or cont | accessdata.fda.gov |
| November 28, 2023 | 93638 | Class II | Ongoing | (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424 | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. | accessdata.fda.gov |
| October 9, 2023 | 93363 | Class II | Ongoing | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted. | accessdata.fda.gov |
| October 9, 2023 | 93362 | Class II | Ongoing | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur | accessdata.fda.gov |
| October 4, 2023 | 93342 | Class II | Ongoing | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing. | accessdata.fda.gov |
| June 12, 2023 | 92727 | Class II | Ongoing | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system. | accessdata.fda.gov |
| June 12, 2023 | 92720 | Class II | Ongoing | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. | accessdata.fda.gov |
| April 25, 2023 | 92202 | Class II | Ongoing | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down | accessdata.fda.gov |
| April 19, 2023 | 95325 | Class II | Ongoing | Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expec | accessdata.fda.gov |
| March 20, 2023 | 92117 | Class II | Ongoing | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury | accessdata.fda.gov |
| March 3, 2023 | 92333 | Class II | Ongoing | ProxiDiagnost N90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA). | accessdata.fda.gov |
| January 18, 2023 | 95301 | Class II | Ongoing | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTA | accessdata.fda.gov |
| January 6, 2022 | 93737 | Class II | Ongoing | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. | accessdata.fda.gov |
| July 15, 2021 | 93739 | Class II | Ongoing | (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359) | The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.) | accessdata.fda.gov |
| December 24, 2020 | 94229 | Class II | Ongoing | PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143 | Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured | accessdata.fda.gov |
| August 10, 2012 | 62844 | Class II | Terminated | Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Doc | Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron | accessdata.fda.gov |
| August 25, 2010 | 58636 | Not yet classified | Terminated | Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache dat | Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power sour | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated October 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.