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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00662-1
Product Name/Description	3D9-3v Transducer (Accessory to Philips Ultrasound Systems : EPIQ Elite, Affiniti 30, 50, and 70, ClearVue 850, HD15, iU22, Compact 5000) Multiple serial numbers Device identifier: 00884838061545 ARTG 289741 (Philips Electronics Australia Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal) ARTG 408665 (Philips Electronics Australia Ltd - Rectal/vaginal ultrasound imaging transducer)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/07/2023
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The 3D9-3v Transducer chassis assembly consists of two parts that are bonded together. The bond between the front and rear parts of the chassis of these transducers may fail. Philips has received complaints associated with this issue; however, there are no reports of injury or serious harm.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers should immediately stop usage and/or distribution of the affected 3D9-3v Transducers and secure them in a location where they cannot inadvertently be used. Circulate the notification to all users of this device so that they are aware of the issue. A Philips representative will contact customers affected to schedule a time for a Field Service Engineer (FSE) to visit their site to provide a replacement device and collect the affected product. This action has been closed out on 26/07/2024
Contact Information	1800 251 400 - Philips Service Delivery Team.