Philips Medical Systems recalls
Philips Medical Systems appears in 82 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 82 |
|---|---|
| Published | 2013-12-11 to 2026-10-14 |
| By agency | FDA Device (82) |
| By classification | Class II (81), Class I (1) |
| By status | terminated (70), ongoing (12) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, US, UT, VA, VT, WA, WI, WY |
Recalls
- Spectral CT and Spectral CT 7500 RT
FDA Device · Class II · 2026-10-14 · Philips Medical Systems
Reason: Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. - IQon Spectral CT IQon Spectral CT Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadeq… - Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadeq… - Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12…
FDA Device · Class II · 2026-08-05 · Philips Medical Systems
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadeq… - Philips Spectral CT on Rails
FDA Device · Class II · 2026-04-22 · Philips Medical Systems
Reason: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of P… - Model: CT 5300
FDA Device · Class II · 2025-11-05 · Philips Medical Systems
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM… - Model: Incisive CT for Brazil SKD
FDA Device · Class II · 2025-11-05 · Philips Medical Systems
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM… - Model: Incisive CT
FDA Device · Class II · 2025-11-05 · Philips Medical Systems
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM… - CombiDiagnost R90 1.1 (709031)
FDA Device · Class II · 2024-02-21 · Philips Medical Systems
Reason: While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image… - CombiDiagnost R90 1.0 (709030)
FDA Device · Class II · 2024-02-21 · Philips Medical Systems
Reason: While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image… - Spectral CT on Rails: Software Version 5.1.0.X, model 728334
FDA Device · Class II · 2024-02-14 · Philips Medical Systems
Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. - Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340
FDA Device · Class II · 2024-02-14 · Philips Medical Systems
Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. - Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems
Reason: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhi… - Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems
Reason: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhi… - Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems
Reason: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhi… - Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the bod…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems
Reason: The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhi… - Foot Switches used with the following systems: Philips Allura Xper Systems
FDA Device · Class II · 2016-04-06 · Philips Medical Systems
Reason: Loss of key image functionality due to a bent pedal of the Footswitch. - Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
FDA Device · Class II · 2016-04-06 · Philips Medical Systems
Reason: Loss of key image functionality due to a bent pedal of the Footswitch. - DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
FDA Device · Class II · 2016-02-10 · Philips Medical Systems
Reason: In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation. - Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024…
FDA Device · Class II · 2015-12-16 · Philips Medical Systems
Reason: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification - Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xpe…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular an…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient. - Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient. - Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascu…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and va…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vasc…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
Reason: Monitor Ceiling Suspension system may fall - Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option
FDA Device · Class II · 2015-12-02 · Philips Medical Systems
Reason: When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8. - Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the…
FDA Device · Class II · 2015-11-18 · Philips Medical Systems
Reason: MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessi… - Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
FDA Device · Class II · 2015-11-11 · Philips Medical Systems
Reason: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery in… - HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The…
FDA Device · Class II · 2015-11-11 · Philips Medical Systems
Reason: MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed - All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
FDA Device · Class II · 2015-10-28 · Philips Medical Systems
Reason: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be posi… - Philips Healthcare DuraDiagnost X- Ray
FDA Device · Class II · 2015-05-27 · Philips Medical Systems
Reason: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 102… - Pinnacle3 Software Version 10.0, Model 459800200841
FDA Device · Class II · 2015-05-27 · Philips Medical Systems
Reason: A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifica… - Philips Healthcare DigitalDiagnost System X-Ray
FDA Device · Class II · 2015-05-27 · Philips Medical Systems
Reason: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 102… - Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067
FDA Device · Class II · 2015-04-01 · Philips Medical Systems
Reason: VCG battery ignited in a VCG unit when recharging. - Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
FDA Device · Class II · 2015-03-18 · Philips Medical Systems
Reason: Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float. - Philips Medical System Allura Xper X-Ray Angiographic
FDA Device · Class II · 2015-03-11 · Philips Medical Systems
Reason: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. - Philips Multi Diagnost Eleva II
FDA Device · Class II · 2015-03-04 · Philips Medical Systems
Reason: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected. - Philips Multi Diagnost Eleva with FlatDetector
FDA Device · Class II · 2015-03-04 · Philips Medical Systems
Reason: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected. - Philips IntelliVue TcG10
FDA Device · Class II · 2015-01-28 · Philips Medical Systems
Reason: Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesi… - HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2015-01-21 · Philips Medical Systems
Reason: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. - Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray…
FDA Device · Class II · 2014-12-24 · Philips Medical Systems
Reason: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location. - Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, ex…
FDA Device · Class II · 2014-12-24 · Philips Medical Systems
Reason: In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. - BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consistin…
FDA Device · Class II · 2014-12-17 · Philips Medical Systems
Reason: It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully. - 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 cra…
FDA Device · Class I · 2014-12-03 · Philips Medical Systems
Reason: Mold on gel filled Gel-E and Squishon products