Intuitive Surgical, Inc. recalls The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (S

Recalled December 1, 2021 · FDA recall Z-0275-2022 · Intuitive Surgical

Hazard

Incorrect expiration date on its package labeling (shipper box and inner carton label). · FDA Class II

Units

1,740 drapes (87 bobes)

Sold at

Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.

Description

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Product

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

Manufacturer(s)

Intuitive Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →