Philips Ultrasound, Inc
FDA adverse event reports naming Philips Ultrasound, Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: PHILIPS ULTRASOUND, INC.
- Total reports
- 1,330
- Deaths
- 21
- Injuries
- 60
- Malfunctions
- 1,248
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- System, Imaging, Pulsed Doppler, UltrasonicIYN1,039
- Transducer, Ultrasonic, DiagnosticITX273
- System, Imaging, Pulsed Echo, UltrasonicIYO8
- System, Image Processing, RadiologicalLLZ4
- System, X-Ray, Tomography, ComputedJAK3
- Automated External Defibrillators (Non-Wearable)MKJ2
- Catheter, Ultrasound, IntravascularOBJ1
Recent recalls
- 2026-03-24Open, ClassifiedDevice Design
Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips OMNI III TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-03-24Open, ClassifiedDevice Design
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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