Recall Z-0133-2023— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-09-20. It names 2 FDA 510(k) clearances: K171294, K131861. Product: da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS). Reason: Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery.
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-20
- 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 X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Reason for recall
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
Data sourced from openFDA. This site is unofficial and independent of the FDA.