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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00172-1
Product Name/Description Uronav, Transperineal option - Stepper with Stand
(stereotactic accessory for use with clinical imaging systems)

Model Number: 980603113091

Serial Numbers 1, 2 or 3

ARTG Number: 230930
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 3/02/2017
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue A problem has been detected in the Transperineal Stepper with Stand. The stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017.
Contact Information 1800 251 400 - Philips Customer Care Centre