TL;DR
Turn quiet afternoons into listening time
- Thousands of audiobooks, podcasts and originals
- Listen on your phone, tablet or Echo — also offline
- Cancel anytime
The FDA issued an Early Alert about Philips Lumify diagnostic ultrasound systems after reports of unexpected transducer re-registration and unstable cable connections that can interrupt scanning. As of September 29, 2026, Philips had reported eight serious injuries and four deaths associated with the issue; the FDA says it is reviewing information, and Philips is developing a software update for the registration problem.
The U.S. Food and Drug Administration has issued an Early Alert about potential scanning disruptions in Philips Lumify diagnostic ultrasound systems, warning that unexpected transducer re-registration or an unstable cable connection can interrupt use and delay care. As of September 29, 2026, Philips had reported eight serious injuries and four deaths associated with the issue; the FDA says it is reviewing information and will update its notice as significant new details become available.
According to the FDA, Philips told affected customers that a software issue in the Lumify Android or iOS application may cause the app to stop recognizing a previously registered ultrasound transducer. The app can then prompt the user to register it again without warning before point-of-care use. Scanning cannot resume until registration is complete, and that process requires a Wi-Fi or cellular connection.
The FDA says Philips has received reports that these unexpected prompts prevented scanning in pre-hospital settings and delayed care. The reported events occurred where Wi-Fi or cellular service was unavailable. Philips is developing a software update to address the registration issue and plans to send customers a follow-up communication when the update is available, including instructions for any actions required.
The alert also describes a separate potential problem: the USB cable connecting a Lumify transducer to a phone or tablet may disconnect or have an unstable connection during use. Philips said it is assessing the cause and working to identify a solution. The FDA’s reported injury and death figures are associated with the issue; the alert does not provide case-by-case details or establish the circumstances of each outcome.
Scanning Risks in Mobile Care
The concern is especially relevant because Lumify is designed for point-of-care ultrasound and can be used outside hospitals, including in ambulances and other mobile or remote settings. In those locations, staff may have limited access to the network connection required to complete re-registration. If scanning stops when clinicians need it, it may delay imaging used to support diagnosis, triage, and treatment decisions.
The FDA warns that the consequences depend on the clinical situation and the patient’s condition: loss of functionality or system failure during a procedure may delay diagnosis or treatment, and those delays could lead to serious injury or death. That warning describes a potential risk, not a claim that every interruption causes harm. The reported eight serious injuries and four deaths make the alert consequential, while the available notice does not spell out how each case was linked to a particular failure mode.
For facilities and clinicians, the immediate issue is operational as well as technical: a portable system may not be available when needed if re-registration requires a connection that cannot be reached, or if the cable connection is disrupted. The FDA’s interim recommendation focuses on planning for that possibility rather than waiting for the software update.
Popular right now
Vitamix Propel Series 750 Professional-Grade Blender, 4 Programs, Black
Breville Bambino Espresso Machine, Brushed Stainless Steel (BES450BSS)
Vitamix 5200 Professional-Grade Blender, 64 oz. Container, Black
As an affiliate, we earn on qualifying purchases.
Affected Lumify Systems and Guidance
The Lumify system combines a Philips transducer, the Lumify application, and a compatible Android or iOS device. It is indicated for diagnostic ultrasound imaging and fluid-flow analysis and is intended for health care settings, including transportable use outside hospitals. The FDA alert lists affected iOS software versions 2.X, 5.0, 5.1.2, and 5.1.3, and Android versions 1.X, 3.X, 4.X, 5.1, and 5.1.1, with associated UDI-DI identifiers.
Philips sent a letter to affected customers on September 24, 2026. The company recommended using Lumify only where Wi-Fi or cellular signals are readily accessible unless a backup ultrasound device is immediately available. It also advised having backup devices or modalities available, circulating the letter to all users, and posting the notice near affected units.
The FDA’s Early Alert is a public notice about a potentially high-risk device issue, not a statement that a software fix has already been released. The agency says it is reviewing information and will keep the public informed as significant new details become available. The listed software versions and device identifiers can help users and facilities check whether their systems are covered by the notice.
““To prevent unintended loss or delays in scanning functionality,” use Lumify where Wi-Fi or cellular signals are readily accessible unless a backup ultrasound device is immediately available.”
— Philips Ultrasound, as summarized by the FDA
Details Still Under Review
The FDA notice does not identify the affected customer count, explain how often either problem has occurred, or provide a breakdown of the eight serious injuries and four deaths Philips reported as associated with the issue. It also does not describe the individual events or specify which involved unexpected re-registration and which involved cable instability. The figures are reported by Philips to the FDA, rather than presented with case details in the alert.
The timing and scope of the software update remain unconfirmed. Philips is still assessing the cause of the USB cable connection problem and has not yet announced a solution for it in the information provided. The alert does not say whether every listed software version experiences the problems, or whether all affected systems have encountered an interruption.
Readers should distinguish between the two reported failure modes: the app may require registration again, which needs a network connection, and the cable may disconnect or become unstable during use. The notice provides interim precautions but does not say that those steps eliminate all risk.
Customer Notices and Software Fix
Philips is expected to send affected customers another communication when the registration software update is available, with directions on any required action. It has also said it will provide updates when it has more information about the cable connection issue. The FDA says it will update its Early Alert page as significant new information emerges.
In the meantime, the FDA relays Philips’ recommendation to use Lumify only where a Wi-Fi or cellular signal is readily accessible unless a backup ultrasound device is immediately available. Customers are also advised to keep backup ultrasound devices or other modalities available, distribute the Philips letter to all device users, and post the notice near affected systems.
U.S. customers with questions, adverse reactions, or quality concerns can contact the Philips Ultrasound Customer Care Solutions Center at (800) 722-9377. Health care professionals and consumers may report adverse reactions or quality problems to the FDA’s MedWatch program. The FDA’s page remains the source for updates on the alert and the agency’s review.
Key Questions
Which Philips ultrasound systems are named in the alert?
The alert lists Lumify diagnostic ultrasound systems running iOS software versions 2.X, 5.0, 5.1.2, or 5.1.3, and Android versions 1.X, 3.X, 4.X, 5.1, or 5.1.1. It also provides UDI-DI identifiers for the listed versions.
What can cause a Lumify scan to stop?
The app may unexpectedly fail to recognize a previously registered transducer and require re-registration. Scanning is unavailable until registration is complete, which requires Wi-Fi or cellular access. A separate reported issue involves a transducer USB cable that may disconnect or have an unstable connection.
What should affected users do now?
Philips recommends using Lumify where Wi-Fi or cellular service is readily available unless a backup ultrasound device is immediately available. It also recommends keeping backup devices or modalities available, sharing its notice with all users, and posting the notice near affected units.
Has Philips released a fix?
The FDA notice says Philips is developing a software update for the registration issue, but does not give a release date. Philips is separately assessing the cable connection issue and has not announced a solution in the information provided.
How can a problem or adverse event be reported?
U.S. customers can call the Philips Ultrasound Customer Care Solutions Center at (800) 722-9377. Health care professionals and consumers can also report adverse reactions or quality problems through the FDA’s MedWatch program.
Source: primary
