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Philips Ultrasound, LLC FDA Recalls
3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Class IIAug 7, 2026Due to software issue with ultrasound system, doppler sample |
| Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,Class IIOct 31, 2025Ultrasound system compatibility issues with Apple devices ru |
| Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201Class IIJul 14, 2022Retroactive: Ultrasound may experience an unexpected automat |