The Recall Desk

Manufacturer

Philips North America

126 recalls in our database name Philips North America as the manufacturing or recalling firm.

What the numbers show

Total
126
Critical
0
Severe
11
Most recent
2026-05-06

Of the 126 recalls from Philips North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 126

  • HighFDA (Devices)·Z-0677-2024·2024-01-17

    Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard

    Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.

    Product
    BrightView, Gamma Camera System, Product Code 882480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2024·2024-01-17

    Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard

    Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.

    Product
    BrightView XCT, Gamma Camera, Product Code 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2024·2024-01-17

    MRI systems at risk of unintended magnet shutdown during power loss

    Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.

    Product
    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0319-2024·2023-11-22

    CT Scanner Software Bug May Cause Gantry to Move to Wrong Position

    Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2024·2023-11-22

    Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations

    Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2024·2023-11-15

    Surgical C-arm systems recalled for missing warning label and spacer

    Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.

    Product
    Zenition 50 & 70 Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0224-2024·2023-11-15

    Philips surgical imaging systems missing warning label and safety spacer

    Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.

    Product
    BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0230-2024·2023-11-15

    Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers

    Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.

    Product
    Veradius Unity Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0227-2024·2023-11-15

    Medical imaging systems recalled for missing safety spacer and warning label

    Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.

    Product
    Integris-Allura IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0228-2024·2023-11-15

    X-ray imaging systems recalled for missing warning label and spacer

    Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.

    Product
    Allura Xper IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2395-2023·2023-08-16

    MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling

    Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2023·2023-08-16

    Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass

    Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2023·2023-08-16

    Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass

    Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2400-2023·2023-08-16

    MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect

    Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2399-2023·2023-08-16

    MRI System Cable Installation Issue During Service Setup

    Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2023·2023-08-16

    Philips Ingenia Elition X MR Systems Diagnostic Cable Installation Issue

    Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2023·2023-08-09

    Philips CT scanner heat exchanger box may detach and cause injury

    The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.

    Product
    Incisive CT-Computed Tomography X-Ray System Model: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2023·2023-08-09

    Incisive CT Computed Tomography System: Metal Mounting Box May Detach

    A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.

    Product
    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2023·2023-08-09

    Philips Incisive CT Scanner Mounting Box Poses Injury Risk

    A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.

    Product
    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2023·2023-08-09

    CT Scanner Metal Mounting Box May Become Expelled, Posing Injury Risk

    Philips is recalling Incisive CT Plus imaging systems due to a metal mounting box that may separate from the rotating scanner and potentially injure users.

    Product
    Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2023·2023-05-24

    Philips Incisive CT System Foot Switch Pedal May Cause Foot Entrapment Injury

    Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.

    Product
    Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2023·2023-05-24

    Philips Incisive CT system foot switch poses entrapment risk during unload

    The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.

    Product
    Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide