Ssy,usm,is4000, Da Vinci Xi Surgical System, Da Vinci X Surgical System
- Recalling firm
- Device Technologies New Zealand
- Product
- SSY,USM,IS4000, da Vinci Xi Surgical System, da Vinci X Surgical System. [Device]. Model: ASSY,USM,IS4000, da Vinci Xi Surgical System, da Vinci X Surgical System. Affected: Product Codes: 380647
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-15
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/b3c9d6f1-5d01-4a5c-881b-1b284e205238