Philips North America Llc: Medical Device Recalls in 2024

According to to data from the FDA, there were 120 medical device recalls made by Philips North America Llc in 2024. See the details of the recalls below.

You can see similar recalls for other firms.

• Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
• dS Breast 16ch 1.5T
• Mammotrak Interventional Coil 1.5T
• Mammotrak Diagnostic Coil 1.5T
• SENSE Breast Coil
• ST SENSE Breast Coil
• Mammotrak Diagnostic Coil 3.0T
• Mammotrak Interventional Coil 3.0T
• dS Breast 7ch 3.0T
• dS Breast 16ch 3.0T
• Achieva TX Interventional Coil 3.0T
• ST SENSE Breast Dx Coil
• SENSE Breast Coil 3.0T 7ch
• IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
• Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
• Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
• SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
• dS Breast 7ch 1.5T
• Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
• Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
• MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120
• Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
• DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
• MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
• Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
• Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
• SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
• IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
• IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
• Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
• Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
• SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
• IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
• IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
• HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
• Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
• HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
• Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
• Intera 1.5T Omni/Stellar, Magnetic Resonance System.
• Intera 1.5T, Magnetic Resonance System.
• Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
• Ingenia Elition S, Magnetic Resonance System.
• Achieva 1.5T Conversion, Magnetic Resonance System.
• Evolution Upgrade 3.0T, Magnetic Resonance System.
• Intera 0.5T Standard, Magnetic Resonance System.
• Ingenia 3.0T, Magnetic Resonance System.
• Ingenia Ambition S, Magnetic Resonance System.
• Intera 1.5T R11, Magnetic Resonance System.
• Intera 1.5T Master/Nova, Magnetic Resonance System.
• Enterprise 1.5T, Magnetic Resonance System.
• Intera 3.0T Quasar Dual, Magnetic Resonance System.
• Intera 1.5T Achieva Nova, Magnetic Resonance System.
• Ingenia 1.5T CX, Magnetic Resonance System.
• Ingenia 1.5T S, Magnetic Resonance System.
• GYROSCAN ACS-NT, Magnetic Resonance System.
• Achieva 1.5T Initial, Magnetic Resonance System.
• Ingenia 1.5T, Magnetic Resonance System.
• GYROSCAN T5-NT, Magnetic Resonance System.
• Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
• Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
• Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
• MR 5300, Magnetic Resonance System.
• Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
• Ingenia Ambition X, Magnetic Resonance System.
• Achieva 3.0T, Magnetic Resonance System.
• SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
• GYROSCAN T10-NT, Magnetic Resonance System.
• MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
• GYROSCAN T5, Magnetic Resonance System.
• MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
• Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
• Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
• Intera CV, Magnetic Resonance System.
• Intera 1.0T Power/Pulsar, Magnetic Resonance System.
• SmartPath to dStream for 1.5T, Magnetic Resonance System.
• Achieva 3.0T for PET, Magnetic Resonance System.
• The Oncology Essentials Package of the Spectral CT imaging system.
• Intera 1.0T Omni/Stellar, Magnetic Resonance System.
• Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
• MR 7700, Magnetic Resonance System.
• Intera 1.5T Power/Pulsar, Magnetic Resonance System.
• Ingenia 3.0T CX, Magnetic Resonance System.
• Achieva 1.5T, Magnetic Resonance System.
• Achieva XR, Magnetic Resonance System.
• Ingenia Elition X, Magnetic Resonance System.
• Achieva 3.0TX for PET, Magnetic Resonance System.
• Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U
• Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
• SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
• MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
• Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
• Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
• SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
• Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
• Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
• Ingenia 1.5T S Model Number (REF): 781347
• Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
• Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
• Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
• Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
• SmartPath to dStream for 3.0T Model Number (REF): 782145
• Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
• Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
• Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
• Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
• MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
• Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
• Achieva 3.0T TX for PET Model Number (REF): 781479
• Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
• Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
• AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
• Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
• Achieva 1.5T Initial system Model Number (REF): 781178
• Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
• SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
• Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
• SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
• SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
• SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
• HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732