Recall Z-1262-2023— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2023-01-24. It names 2 FDA 510(k) clearances: K171294, K131861. Product: Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000. Reason: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-24
- 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
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
Reason for recall
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.