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TGA Action ID	RC-2026-RN-00790-1
Type of Product	Medical Device
Product Name/Description	Philips Lumify Diagnostic Ultrasound System Model Numbers: 300016286781, 453561733324, 453561733325, 453561733326, 453561733327, 453561733328, 453561733329, 453561734013, 453561734014, 453561734015, 453561734016, 453561734016, 453561734017, 453561734018, 453561738971, 453561738972, 453561738973, 453561738974, 453561738975, 453561738976, 453561931882, 453561931893, 989605434813, 453561733327 All Software is impacted: Android versions: 1.X, 3.X, 4.X, 5.X iOS Versions: 2.X and 5.X
ARTG Number	414544, 414547
Unique Device Identifier (UDI)	Refer to the customer notification letter.
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class I
Reason for the Action	Philips has identified the following potential problems with the Lumify Diagnostic Ultrasound System which may prevent or delay scanning functionality: 1. The Lumify application may not recognize a previously registered transducer and prompt for re-registration (outside of the defined criteria in the User Guide) without warning prior to point-of-care use. Scanning functionality is prevented until the registration step has been completed; registration requires Wi-Fi or cellular signal access. 2.The connection between the Lumify transducer USB cable to a customer’s tablet/ phone may disconnect or have an unstable connection during use which may disrupt continuous function of the device and result in a delay of care. Since the launch of Lumify in 2015, Philips Ultrasound has received four (4) reports of death and eight (8) reports of serious injury associated with the Lumify system not being available/ functional at the point of care.
Instructions for Customers/Users	Philips advises customers/ users to take the following actions to reduce risks for patients until a software update is available and installed: • Do not use the Lumify system outside of areas with readily accessible Wi-Fi/Cellular (e.g. pre-hospital transport (ambulance, helicopter) or use outside of a traditional healthcare setting (care in the field). • Always have backup ultrasound devices and/or modalities available for care as advised in the User Guide. Philips is developing a software update to address the identified registration problem and assessing the unstable cable connection problem and identify the appropriate solution. Philips will communicate again once the software update is available and provide instructions on any actions required for these problems Please contact your local Philips representative with any additional questions or to report any problem with your device.
Action Commencement Date	19/10/2026
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team