The Recall Desk

Manufacturer

Philips Medical Systems, Inc.

65 recalls in our database name Philips Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
65
Critical
0
Severe
14
Most recent
2016-04-06

Of the 65 recalls from Philips Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (22%) 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.

26–50 of 65

  • ModerateFDA (Devices)·Z-0997-2015·2015-01-28

    Philips IntelliVue TcG10 Monitor Recalled for Missing Contraindication Warning

    Philips is recalling 86 IntelliVue TcG10 monitors because the instructions for use are missing a warning against using the device on patients under gas anesthesia.

    Product
    Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0963-2015·2015-01-21

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.

    Product
    HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2015·2014-12-24

    Philips Brilliance iCT Computed Tomography System Software Defect Recall

    Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different ang
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0508-2015·2014-12-24

    Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk

    Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.

    Product
    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lyi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0203-2015·2014-12-17

    Philips Recalls BrightView XCT Gamma Cameras Due to CT Scan Interruptions

    Philips Medical Systems is recalling BrightView XCT gamma cameras because the CT portion of scans may be interrupted and fail to complete successfully.

    Product
    BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2015·2014-12-03

    Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold

    Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.

    Product
    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2015·2014-11-19

    Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault

    Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.

    Product
    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0182-2015·2014-11-19

    Philips Allura Xper FD20C Recalled for Faulty Motion Controller

    Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.

    Product
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and m
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0105-2015·2014-10-29

    Philips Avalon Fetal Monitors Recalled for Software Measurement Error

    Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.

    Product
    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2015·2014-10-29

    Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage

    Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.

    Product
    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1864-2014·2014-07-02

    Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Hardware

    Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of stainless steel nuts.

    Product
    Ingenia 3.0T, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2014·2014-07-02

    Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Nut Components

    Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 3.0T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2014·2014-07-02

    Philips Recalls Ingenia MRI Systems Due to Incorrect Nut Material

    Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 1.5T, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1863-2014·2014-07-02

    Philips Recalls Ingenia 1.5T MRI Systems Due to Incorrect Hardware

    Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.

    Product
    Ingenia 1.5T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2014·2014-06-25

    Philips Ingenia FlexTrak Trolley Recalled for Foot Clamping Hazard

    Philips is recalling Ingenia HA FLEX TRAK Trolleys because the central column can clamp a patient's foot. The recall covers 420 units distributed worldwide.

    Product
    Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2014·2014-06-25

    Philips MR Trolley Recall for Foot Clamping Hazard

    Philips is recalling Height Adjustable FlexTrak trolleys and Trolley Variable Height IRFs for Ingenia MR systems due to a risk of foot clamping.

    Product
    Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2014·2014-06-18

    Philips IntelliVue MX40 Wearable Patient Monitor Alarm Failure Recall

    Philips is recalling IntelliVue MX40 monitors because alarms may not resume after being paused, potentially delaying clinical response.

    Product
    IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2014·2014-05-28

    Philips Recalls Lithium Ion Batteries for IntelliVue Patient Monitors

    Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.

    Product
    Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2014·2014-04-30

    Philips Digital Diagnost Radiographic System Recall Due to Footboard Defect

    Philips is recalling 985 Digital Diagnost stationary radiographic systems because the footboard may not be securely held if the fix clamp is not correctly adjusted.

    Product
    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2014·2014-04-30

    Philips MDC PACS and IntelliSpace PACS DCX Software Recall for Density Errors

    Philips is recalling MDC PACS and IntelliSpace PACS DCX software because it may display incorrect density measurements on Enhanced CT and MR examinations.

    Product
    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliS
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Philips Medical Systems

company based in Hamburg, Germany

Country
Germany
Founded
1987
Parent company
Philips (Germany)

Official website

Source: Wikidata (Q2087959), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.