DeviceClearance

Recall Z-3254-2018— Intuitive Surgical, Inc.

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-07-16, terminated 2023-10-05. It names 3 FDA 510(k) clearances: K171294, K131861, K081137. Product: da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.. Reason: Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use..

Recalling firm
Intuitive Surgical, Inc.
Classification
Class II
Status
Terminated
Initiated
2018-07-16
Terminated
2023-10-05
Firm location
Sunnyvale, CA, United States

510(k) clearances named in this recall

3 on FDA's record

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 Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.

Reason for recall

Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.