| TGA Action ID |
RC-2026-RN-00036-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Lumify Systems
in combination with devices that have a USB-C connector |
| ARTG Number |
414544 |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is an incompatibility problem with the Lumify System and devices that are running iOS 18.X and have a USB-C connector.
With version 18.X of iOS, when the device’s charge level drops below 99%, it will attempt to charge from the Lumify Power Module through the USB connection. This does not happen for Lightning port connected devices.
If the battery threshold is crossed while live scanning, the application will interrupt the live scan and display a dialog message requiring the user to charge the tablet. If the battery level is below the threshold prior to starting live scanning the application will prevent live scanning from starting and display a dialog message requiring the user to charge the tablet.
Philips has received customer complaints regarding this problem. To date, Philips has not received any reports of patient harm. |
| Instructions for Customers/Users |
Customers are to:
- Utilise an Android based device or an iOS device with a Lightning port with their Lumify system.
- If customers use an iOS based device with a USB-C connector, they should not update their device to iOS 18.X and turn off auto-updates.
Philips will notify customers when an updated Lumify software version is available to resolve this problem.
Update: 25/6/2026: Philips anticipates the updated Lumify software version iOS 5.1.3 will be available by Q3 2026. Instructions on how to download the update once available are included in the customer letter.
Update 29/10/26: Lumify version 5.1.3 was released in Australia on 27 July 2026. The app was removed from Apple and Google app stores on 13 August 2026 following a software hold linked to market action 2026-PD-US-010.
The hold addresses a software problem that may incorrectly require re-registration of registered transducers.
Without Wi-Fi or cellular connectivity, scanning may be unavailable until registration is complete.
Philips is developing an update to fix the registration problem and will advise when it is available and what actions are required. |
| Action Commencement Date |
22/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |