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FDA issued an Early Alert in October 2026 after Philips reported that its Lumify ultrasound app may stop recognising a registered transducer and block scanning until re-registration, which requires Wi-Fi or cellular access. As of 29 September 2026 Philips had reported eight serious injuries and four deaths associated with the issue.
PathConnectivity & data → Devices
TierFDA documents that scanning was prevented and care delayed in pre-hospital settings, but not what care fell back to. How tiers are assigned.
According to FDA's Early Alert, a software issue can cause the Philips Lumify Diagnostic Ultrasound System app to stop recognising a previously registered transducer and prompt users to re-register without warning. Scanning is blocked until registration is complete, and registration requires Wi-Fi or cellular signal access. Philips received reports that these re-registration events prevented scanning and delayed care in pre-hospital settings; MedTech Dive notes that Lumify is deployed in ambulances, aircraft and field settings. A separate issue is that the USB connection between the transducer and the phone or tablet may disconnect or become unstable during use. As of 29 September 2026, Philips had reported eight serious injuries and four deaths associated with the issue, according to FDA. Affected app versions include iOS 2.X, 5.0, 5.1.2 and 5.1.3 and Android 1.X, 3.X, 4.X, 5.1 and 5.1.1. Philips, which wrote to customers in September, advised using the system only where Wi-Fi or cellular signal is readily available unless a backup ultrasound device is immediately available. A Philips spokesperson told MedTech Dive that the company is developing a software update, is working on a solution to the USB issue and has set up a dedicated taskforce to support affected customers.[1,2]
Philips reported eight serious injuries and four deaths associated with the issue as of 29 September 2026 (FDA); FDA does not state that the device caused them.
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