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TGA Action ID	RC-2026-RN-00227-1
Type of Product	Medical Device
Product Name/Description	Intra uterine tube with 4 mm diameter Affected Components: CT/MR Applicators (Standard, Ring, Fletcher, Utrecht Interstitial), Advanced Gynecological Applicator - Venezia, Geneva All versions
ARTG Number	378375, 381348
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Elekta are informing customers of a safety concern regarding the detachment of the tip of the Intrauterine tube (IU tube) with a 4mm diameter. Inadequate application of the epoxy adhesive between the tip and the inner and end surfaces of the fibre tube may contribute to tip detachment. If the tip detaches during a procedure and is retained in the body there is risk of reduced fertility, inflammation and pain.
Instructions for Customers/Users	Customers are to adhere to the instructions for use: • Do not use an IU tube beyond its 3-year life expectancy or 300 reprocessing cycles, whichever comes first. • During the treatment preparation phase, before insertion of the applicator: Visually inspect parts for indication of damage, weakening, bending, cracks, corrosion, or general deterioration. • Inspect joints and connections on play, strength or other forms of degradation. In addition, customers are to: • Inspect the end of the IU tube to ensure that there is no gap between the tip and the fibre tube and that the tip is not detached. • During inspection, insertion and removal: avoid the use of excessive force that could damage the IU tube. • After removal: Ensure that all applicator parts have been removed from the patient and that the tip is not detached. If users find a damaged or detached IU tube tip, remove it from clinical use and contact Elekta for a replacement.
Action Commencement Date	27/03/2026
Responsible Entity	Nucletron Pty Limited
Contact Information	02 8907 1800 - Elekta