The Recall Desk

Manufacturer

Philips Electronics North America Corporation

160 recalls in our database name Philips Electronics North America Corporation as the manufacturing or recalling firm.

What the numbers show

Total
160
Critical
0
Severe
19
Most recent
2018-12-26

Of the 160 recalls from Philips Electronics North America Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (12%) 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 160

  • HighFDA (Devices)·Z-3236-2018·2018-10-03

    Philips Allura Xper F020 Biplane DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 Biplane DR Tables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3237-2018·2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator rotor shaft and fall, posing a risk of injury to patients, users, and bystanders.

    Product
    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3235-2018·2018-10-03

    Philips Allura Xper F010/10 DRTable Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F010/10 DRTables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2018·2018-10-03

    Philips FlexVision Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and bystanders.

    Product
    AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2894-2018·2018-08-29

    Philips SureSigns VS4 Vital Signs Monitor Recalled for Battery Fire Risk

    Philips is recalling SureSigns VS4 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2895-2018·2018-08-29

    Philips SureSigns Patient Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VM, VS, and VSV patient monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2893-2018·2018-08-29

    Philips SureSigns VS3 Vital Signs Monitor Recall for Battery Fire Risk

    Philips is recalling SureSigns VS3 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2896-2018·2018-08-29

    Philips SureSigns VS2 Monitor Recall for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VS2 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2892-2018·2018-08-29

    Philips SureSigns VSV Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VSV monitors because lithium-ion batteries may overheat or ignite if not replaced on schedule, posing fire and injury risks.

    Product
    Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recalled for Missing Warning Statements

    Philips is recalling 7,178 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1589-2018·2018-05-09

    Philips Allura Xper and UNIZ Systems Recalled for Monitor Freezing

    Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.

    Product
    Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applica
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1442-2018·2018-04-25

    Philips T5 MRI Scanner Recalled for Helium Gas Risk

    Philips is recalling T5 MRI scanners due to a potential risk of helium gas release during a magnet quench.

    Product
    T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2018·2018-04-25

    Philips Achieva 1.5T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 Achieva 1.5T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2018·2018-04-25

    Philips MRI Software Recall Due to Helium Gas Risk During Quench

    Philips is recalling the SmarthPath to dStream conversion software for 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.

    Product
    Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2018·2018-04-25

    Philips Multiva MRI Systems Recalled for Helium Gas Quench Risk

    Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2018·2018-04-25

    Philips Multiva MRI Systems Recalled for Helium Gas Risk During Quench

    Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release in the examination room during a magnet quench.

    Product
    Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2018·2018-04-25

    Philips Intera 1.0T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 Intera 1.0T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2018·2018-04-25

    Philips ACS-NT MRI Scanner Recalled for Helium Gas Leak Risk

    Philips is recalling 8,205 ACS-NT MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2018·2018-04-25

    Philips T5-NT MRI Scanner Recalled for Helium Gas Risk

    Philips is recalling 8,205 T5-NT MRI scanners worldwide due to a potential risk of helium gas release in the examination room during a magnet quench.

    Product
    T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2018·2018-04-25

    Philips Intera 1.5T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling Intera 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2018·2018-04-25

    Philips Intera 0.5T MRI Recalled for Helium Gas Risk

    Philips is recalling 8,205 Intera 0.5T MRI scanners worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide