FDA Warns of Philips Lumify Ultrasound Software Fault After Reports of Four Deaths

The United States Food and Drug Administration (FDA) has issued an early safety alert concerning Philips Lumify diagnostic ultrasound systems after reports of software and connectivity problems that could interrupt scanning and delay patient care.

The issue affects certain Lumify systems that operate through compatible Android and iOS devices. According to the FDA, the application may unexpectedly fail to recognise a previously registered ultrasound transducer and request that it be registered again before scanning can resume. The registration process requires an active Wi-Fi or cellular connection, which may not be available in every clinical setting.

The problem is particularly concerning in ambulances, aircraft and other pre-hospital environments where network access can be unreliable. Philips has received reports of unexpected registration requests that prevented ultrasound examinations from proceeding, resulting in delays to patient care.

A second issue involves the USB cable connecting the ultrasound transducer to a compatible phone or tablet. The connection may become unstable or disconnect during use, interrupting the system's operation and potentially delaying diagnosis or treatment.

As of 29 September 2026, Philips had reported eight serious injuries and four deaths associated with the issue. The FDA cautioned that a loss of functionality during point-of-care examinations could have serious consequences, depending on the patient's condition and the urgency of treatment.

Philips has advised healthcare providers to use affected systems only where Wi-Fi or cellular connectivity is readily available, unless a backup ultrasound device is immediately accessible. Facilities have also been advised to inform relevant staff about the problem and ensure that alternative imaging equipment is available when needed.

The manufacturer is developing a software update to address the registration fault and is investigating the unstable cable connection. The FDA stated that it is reviewing the available information and will publish further updates as significant developments emerge.

09-10-2026