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.

51–75 of 160

  • HighFDA (Devices)·Z-1437-2018·2018-04-25

    Philips Ingenia 1.5T CX MRI Recall for Helium Gas Risk

    Philips is recalling Ingenia 1.5T CX MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    Ingenia 1.5T CX, Models 781261 & 781262 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-1434-2018·2018-04-25

    Philips Panorama 1.0T MRI Recalled for Helium Gas Release Risk

    Philips is recalling Panorama 1.0T MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    Panorama 1.0T, Model 781250 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
  • LowFDA (Devices)·Z-0978-2018·2018-03-21

    Philips HeartStart XL+ Defibrillator Software Update Recall

    Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.

    Product
    HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0850-2018·2018-03-14

    Philips Network Firewall Recall Due to Defective Clock Component

    Philips is recalling 332 network firewalls used with IntelliVue systems due to a defective clock component that may cause loss of connection.

    Product
    Philips Network Firewall (Cisco ASA 5506), Model # 867098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2018·2018-03-07

    Philips Intellivue iX Software Recall for Patient Discharge Failure

    Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.

    Product
    Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Da
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0717-2018·2018-03-07

    Philips Allura Xper FD X-ray Systems Recalled for Monitor Fall Hazard

    Philips is recalling 1,486 Allura Xper FD and ORT X-ray systems because extra monitors mounted on the ceiling suspension may disengage and fall.

    Product
    Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2018·2018-03-07

    Philips Recalls Allura Xper Systems Due to Anode Drive Unit Failure

    Philips is recalling 705 Allura Xper systems because Anode Drive Units may fail in high-voltage regions, reducing X-ray performance to emergency mode.

    Product
    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2018·2018-03-07

    Philips ProGrade R1 Digital X-Ray Detector Recall for Image Transfer Failures

    Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.

    Product
    digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Instruction and Injury Information

    Philips is recalling QCPR meters to inform users of correct pad placement and injuries associated with CPR performance.

    Product
    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Feedback and Injury Information

    Philips is recalling QCPR meters used with HeartStart defibrillators to inform users of correct pad placement and CPR-related injuries.

    Product
    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2018·2018-01-24

    Philips Recalls ECG Out Cables Due to Electrical Interference Risk

    Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.

    Product
    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0330-2018·2018-01-17

    Philips CombiDiagnost R90 X-Ray System Recalled for Electrical Safety Defect

    Philips is recalling 10 CombiDiagnost R90 X-ray systems because a protective earthing wire was removed and non-standard spacers were used.

    Product
    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0311-2018·2018-01-10

    Philips Mobile Detector Holder Recalled Due to Potential Detector Drop Hazard

    Philips is recalling 412 Mobile Detector Holders for Stationary X-ray Systems because the lock mechanism may fail, causing the detector to drop.

    Product
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0292-2018·2018-01-03

    Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display

    Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.

    Product
    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the phys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0278-2018·2017-12-27

    Philips HeartStart MRx Defibrillators Recalled for EtCO2 Module Contamination

    Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.

    Product
    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0255-2018·2017-12-27

    Philips Medical Imaging Systems Recalled for Measurement Export Error

    Philips is recalling 157 medical imaging systems because a software option prevents correct export of measurement data to external destinations.

    Product
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0268-2018·2017-12-27

    Philips SureSigns Vital Signs Monitors Recalled for Labeling Error

    Philips is recalling SureSigns VSi and VS2+ vital signs monitors because some units have a placeholder date of manufacture instead of the specific date.

    Product
    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0020-2018·2017-10-25

    Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2018·2017-10-25

    Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure

    Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2018·2017-10-25

    Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure

    Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2018·2017-10-25

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2018·2017-10-25

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.

    Product
    Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2018·2017-10-25

    Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure

    Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.

    Product
    Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide