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TGA Action ID	RC-2025-RN-00721-1
Type of Product	Medical Device
Product Name/Description	Philips Ultrasound Transducers Models: 3D9-3v, C5-1, C5-2, C9-5ec, eL18-4, eL18-4 EMT, L12-3, L12-4, V6-2, L8-4, VL13-5, L9-3, X5-1, S5-1, X6-1, S7-2, X7-2t, S7-3t, X8-2t, S8-3t, XL14-3
ARTG Number	414545, 414547, 414618, 462674
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Philips is recalling certain Ultrasound transducers that were refurbished beyond their designated useful life. The company has not received any reports of patient harm associated with these refurbished transducers. Based on Philips’ risk assessment it was determined that there are no new hazards introduced which are associated with the use of transducers refurbished after their useful life.
Instructions for Customers/Users	- Customers are advised that Philips will replace any transducers that have been refurbished beyond their intended service life with new units. In the meantime, the refurbished transducers may continue to be used, provided they are operated according to the instructions outlined in the Transducer section of the User Manual. - Users should pay close attention to visual inspections and electrical safety testing. If a refurbished transducer fails inspection, it must be removed from clinical use immediately, and Philips should be contacted immediately. - Philips representative will contact customers to schedule a visit by a Field Service Engineer who will provide a replacement transducer and collect the affected productt
Action Commencement Date	18/08/2025
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251400 - Customer Support