Philips North America Llc: Medical Device Recalls in 2023

According to to data from the FDA, there were 35 medical device recalls made by Philips North America Llc in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

• DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
• DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
• DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
• CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
• DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
• ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
• DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
• DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
• DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
• Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
• EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
• Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154
• Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
• EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
• EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
• Achieva 1.5T Initial System
• Achieva 1.5T Conversion
• Intera 1.5T
• SmartPath to dStream for 1.5T
• Intera 1.5T Power/Pulsar
• Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
• Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
• EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
• EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
• ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
• Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
• DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
• Ingenia 1.5T CX
• Achieva 1.5T
• CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
• Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
• The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
• DigitalDiagnost C90, Model No. 712034 and 712035
• Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
• Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.