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TGA Action ID	RC-2025-RN-00604-1
Type of Product	Medical Device
Product Name/Description	da Vinci X and Xi Surgical Systems, X ASSY, USM, IS4000 Part number: 380647 Serial numbers: SK0569, SK0613, SK0737, SK0739, SK0826, SK0942, SK1292, SK1787, SK1832, SK5905, SK6167, SK6170, SK6206, SK6267, SK6518, SK6678, SK6720, SK6721, SK6723, SK7017, SK7018, SK7019, SK7317, SK7374, SK7499, SL0474
ARTG Number	97348
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	The da Vinci X and Xi system instrument arms (USMs) have Instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor, preventing free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail, which can lead to increased friction along the insertion axis.
Instructions for Customers/Users	Customers are advised that: · Prior to each use, all Instrument Carriages on affected da Vinci X and Xi systems must be inspected using the ‘Instrument Carriage Inspection Instructions’. · If an Instrument Carriage fails the inspection or raises any concern, the USM must not be used and Device Technologies should be notified. If three out of four USM Instrument Carriages pass the inspection, the da Vinci X or Xi system may be used in accordance with the instructions in the Three-Arm Procedure section of the da Vinci X and Xi systems user manual. · They should continue to follow the instructions in the da Vinci X and Xi User Manual and always hold the USM/arm by its grey handle when manually moving or positioning the arm. · The Instrument Carriage must not be used to manually reposition the USM when the system is powered off or in a fault condition. In the event of an emergency where this action is unavoidable, the affected USM must no longer be used and Device Technologies should be notified immediately. · A Device Technologies representative will arrange a site visit to inspect the insertion linear rail and replace the USM if necessary. This action has been finalised on 11/9/2025.
Action Commencement Date	8/07/2025
Responsible Entity	Device Technologies Australia Pty Ltd
Contact Information	1300 338 423 - Device Technologies Australia Pty Ltd Customer Service