Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:37552
Brand Name:SSY,USM,IS4000, da Vinci Xi Surgical System, da Vinci X Surgical System
Model:ASSY,USM,IS4000, da Vinci Xi Surgical System, da Vinci X Surgical System
Affected:Product Codes: 380647
Software version:
Recalling Organisation:Device Technologies New Zealand
47 Arrenway Drive
Albany
AUCKLAND 0632
Contact Information:09 913 2000
Manufacturer:Intuitive Surgical Inc
Issue:The manufacturer has identified that the screws on the cannula mount of the USM are from a specific population that are susceptible to breaking over time. When the cannula mount experiences a breakage of all six screws, the cannula mount can separate from the rest of the USM. Breakage of any fewer than six screws will not result in cannula mount separation, or impact to clinical performance.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:15/9/2026
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