Recall Z-1484-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-1484-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-22

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-06-22. It names one FDA 510(k) clearance: K191280. Product: The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.. Reason: Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-22
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K191280 — E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.·cleared 2019-11-14

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

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.

Reason for recall

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

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