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FDA issues Class I recall for Philips ultrasound
Eight serious injuries and 4 deaths were reported in association with device issues involving software and connectivity that could disrupt point-of-care imaging.
Clinical Scorecard: FDA issues Class I recall for Philips ultrasound
At a Glance
Category
Detail
Condition
Philips Lumify diagnostic ultrasound system functionality issues
Key Mechanisms
Software may unexpectedly require transducer re-registration, which requires Wi-Fi or cellular connectivity; unstable or disconnected USB connections may interrupt imaging.
Target Population
Patients examined using affected Philips Lumify systems.
Care Setting
Point-of-care ultrasound, including ambulances, aircraft, and field settings where network access may be limited.
Key Highlights
The FDA classified the correction as a Class I recall on October 19, following an October 9 early alert.
As of September 29, 2026, 8 serious injuries and 4 deaths were associated with device functionality issues.
Unexpected transducer re-registration can prevent scanning until registration is completed using Wi-Fi or cellular connectivity.
USB connection problems may interrupt continuous imaging and delay care.
The recall involves updated operating instructions rather than device removal.
Guideline-Based Recommendations
Diagnosis
Management
Philips instructed customers to use Lumify systems only where Wi-Fi or cellular connectivity is readily accessible, unless a backup ultrasound device is immediately available.
Philips recommended maintaining alternative imaging capabilities and distributing safety notices to device users.
Monitoring & Follow-up
Risks
Loss of ultrasound functionality may interfere with rapid diagnosis, treatment decisions, and triage of unstable patients.
Depending on clinical circumstances, resulting delays could cause serious injury or death.
Patient & Prescribing Data
Patients examined using affected Lumify systems; the article does not provide patient-level demographic or prescribing data.
The article describes device-use precautions, not patient treatment regimens. Philips is developing a software update for unexpected re-registration and separately evaluating the USB connectivity problem.
Clinical Best Practices
Use affected Lumify systems only where Wi-Fi or cellular connectivity is readily accessible, unless a backup ultrasound device is immediately available.
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