Recall Z-1293-2023— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2023-02-10. It names 2 FDA 510(k) clearances: K171294, K131861. Product: da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200. Reason: Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-10
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K171294 — da Vinci X Surgical System
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Reason for recall
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.