Philips Healthcare

Reports per year

Source: FDA adverse event reports by year received, 2008–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Automated External Defibrillators (Non-Wearable)MKJ2,933
• System, X-Ray, AngiographicIZI578
• System, Nuclear Magnetic Resonance ImagingLNH358
• Interventional Fluoroscopic X-Ray SystemOWB259
• Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX162
• System, X-Ray, MobileIZL78
• System, X-Ray, Fluoroscopic, Image-IntensifiedJAA56
• Dc-Defibrillator, Low-Energy, (Including Paddles)LDD40
• Display, Cathode-Ray Tube, MedicalDXJ25
• System, X-Ray, StationaryKPR23

Recent recalls

• 2026-01-08Open, ClassifiedRadiation Control for Health and Safety Act

  Philips Incisive CT

  Potential for incomplete scan due to unstable connection inside of floating sensor.

• 2024-01-05Open, ClassifiedSoftware design

  Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

  Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

• 2023-09-30Open, ClassifiedRadiation Control for Health and Safety Act

  Incisive CT, software version 5.0

  Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

• 2016-06-03TerminatedRadiation Control for Health and Safety Act

  Philips Healthcare DigitalDiagnost stationary X-ray system

  The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

• 2016-06-03TerminatedRadiation Control for Health and Safety Act

  Philips Healthcare DuraDiagnost stationary X-ray system

  The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

• 2014-08-16TerminatedSoftware design

  Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

  A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

• 2014-06-11TerminatedSoftware design

  Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

  If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.

• 2014-05-21TerminatedSoftware design

  Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.

  When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed

• 2014-01-27TerminatedNonconforming Material/Component

  InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

  Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.

• 2013-11-13TerminatedSoftware in the Use Environment

  Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

  Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.