By: Akanksha

Four patients have died and eight more have suffered serious injuries after software and connectivity glitches in Philips Ultrasound’s Lumify diagnostic sonography systems caused the devices to become unresponsive at critical times. The U.S. The Food and Drug Administration (FDA) issued an early alert and recall notice for the Lumify line of diagnostic scans on October 9. Early alerts are issued when a medical product may pose a significant risk to the public prior to a final classification decision.

Philips started sending out notices to customers last month with a letter dated September 24, 2026, that informed them of recommended revised instructions for the use of all Philips Lumify diagnostic ultrasounds. Philip Ultrasound has reported four deaths and eight instances of serious injury related to the devices as of September 29, 2026. The FDA has not classified the recall or established a date for a permanent repair, but said it is reviewing the situation closely and will provide additional information as the case develops. 

How Does the Software Bug Prevent Transducer Recognition? 

The Lumify system consists of a portable Philips transducer and the Philips Lumify mobile application plus an additional plus an Android or iOS-compatible phone or tablet that together enable the diagnostic scanning and analysis of fluids in the body. 

According to the FDA and Philips Ultrasound, the Android and iOS versions of the application contain a software bug that prevents the software from detecting an already registered account or transducer. When the error occurs, the app will advise the operator to re-register the device unexpectedly just before using it for a point-of-care scan. Scanning is disabled completely until the re-registration is performed, which takes some time and requires a Wi-Fi or cellular data connection to be active. 

Also Read: Portable Ultrasound Systems: The Pocket-Sized Technology Changing Modern Medicine

What Is Causing the USB Cable Connection Failure? 

In addition to the software hiccup, Philips has discovered a separate hardware issue involving the USB cable that connects the Lumify transducer to the user’s phone or tablet. The cable can become unsecured or disconnected while a scan is in progress, thereby interrupting the continuity of the operation and delaying treatment. Philips is currently investigating the cause of the cable malfunction and is working on a remedy. 

Where Is the Lumify Ultrasound System Intended to Be Used? 

The Lumify is meant to be a portable and versatile diagnostic tool that can be deployed in a variety of settings, including ambulances, airplanes and elsewhere. As the FDA notes in its alert, the system is “designed for use in a variety of clinical settings including, but not limited to, point-of-care settings where ultrasound imaging provides rapid diagnosis and treatment; real-time decision making; triage of unstable patients; access to diagnostic imaging modalities in mobile, underserved or remote settings.”

Why Are Remote and Field Environments at Higher Risk? 

Because the Lumify is used in an environment where the patient can potentially be in a precarious state, and where a delay in care can have more severe implications than in a conventional, stationary hospital setting, a system malfunction or the loss of a signal has significantly more serious consequences than it would with a traditional ultrasound machine. In underserved and remote areas, a clinician may not have an alternative means of scanning. 

Devices that are deployed in ambulances, airplanes, and elsewhere stand to have more severe consequences tied to the loss of a Wi-fi or cellular connection, because such areas are likely to have either of the two. Philips has already received reports of clinicians being unable to perform a scan in pre-hospital environments where they did not have cellular or Wi-fi coverage due to the scan's unexpected re-registration prompt, which delayed care. The FDA warned that depending on the patient’s condition and the context of the emergency, such a postponement of care  could result in serious injury or death. 

When will a Permanent Software and Hardware Fix Be Available? 

Philips notes that it is currently working on a software update to resolve the registration issue and will provide additional instructions once a permanent software fix and resolution for the USB malnutrition are available. 

What Steps Is Philips Taking to Support Affected Customers? 

“Philips recognizes the role of the Lumify Ultrasound system in access to care,” a Philips representative said to MassDevice. “Our Ultrasound business has formed a task force to address this situation urgently, including providing customized advice and support to affected customers.”

In a separate statement to Radiology Business on Friday, the manufacturer noted that it has taken steps to bolster the safety of its products: “Philips has intensified its efforts to strengthen a patient safety and quality culture throughout the company. We are systematically working through product quality at all levels and businesses as part of a multi-year program. We respond to post-market surveillance signals by proactively issuing corrections, updates or recalls when we identify potential issues.”

For those providers that use the Lumify system in undeserving areas, the Philips Foundations is working with local experts to provide further assistance and support continued access to care.

The recall notice covers nine versions of the Lumify Diagnostic Ultrasound System software for iOS and Android. Each version has a Unique Device Identifier (UDI), a code that is used to track medical devices through the distribution chain and clinical use in order to facilitate the reporting, evaluation, and resolution of adverse events.

Which iOS and Android Versions Are Included in the Recall? 

What Are the Updated Use Instructions for Hospitals and Clinicians? 

Until a permanent resolution is available, the FDA and Philips are recommending hospitals and clinicians use the affected devices with caution and prepare an imaging “Plan B” for when one is needed. 

According to the letter from Philips Ultrasound dated September 24, 2026, providers should use the Lumify system in areas that have access to readily available and reliable Wi-fi or cellular service unless they have an alternative ultrasound machine available for immediate use, and keep backup ultrasound devices or alternative imaging modalities on standby for use at all times. Facilities using the systems should ensure that all staff members receive a copy of the Philips warning letter, and post a copy near the affected units for reference.

Also Read: How Ultrasound Delivery Method Shapes Blood–Brain Barrier Opening, Offering Safer Brain Tumor and Alzheimer’s Therapy

U.S. customers who experience quality issues, adverse reactions, or have questions about the notice can contact the Philips Ultrasound Customer Care Solutions Center at (800) 722-9377. Healthcare workers and consumers can also report directly to the FDA through the agency’s MedWatch Safety Information and Adverse Event Reporting program.

Reference:

U.S. Food and Drug Administration. “Early Alert: Diagnostic Ultrasound System Issue—Philips Ultrasound.” FDA. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-diagnostic-ultrasound-system-issue-philips-ultrasound

(Rh/APC/MSM)