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Philips North America Recalls
530 recalls on record · April 5, 2017 to July 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Intera 1.5T Power/Pulsar
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Intera 1.5T
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Ingenia 1.5T CX
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Initial System
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Conversion
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 22, 2023Medical DevicesFDA
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Hazard: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
November 22, 2023Medical DevicesFDA
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Hazard: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
November 22, 2023Medical DevicesFDA
Philips North America Llc recalls Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed fo
Hazard: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
November 22, 2023Medical DevicesFDA
Philips North America Llc recalls Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati
Hazard: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
November 22, 2023Medical DevicesFDA
Philips North America Llc recalls Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo
Hazard: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America recalls Veradius Unity Mobile Surgery C-arm
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
November 15, 2023Medical DevicesFDA
Philips North America recalls Azurion IGTS Fixed Systems
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
November 15, 2023Medical DevicesFDA
Philips North America recalls Allura Xper IGTS Fixed Systems
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
November 15, 2023Medical DevicesFDA
Philips North America recalls Integris-Allura IGTS Fixed Systems
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
November 15, 2023Medical DevicesFDA
Philips North America recalls Zenition 50 & 70 Mobile Surgery C-arm
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
November 15, 2023Medical DevicesFDA
Philips North America recalls BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Hazard: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
October 11, 2023Medical DevicesFDA
Philips North America Llc recalls EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si
Hazard: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
October 11, 2023Medical DevicesFDA
Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan
Hazard: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
September 27, 2023Medical DevicesFDA
Philips North America Llc recalls Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr
Hazard: Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients