Home / Recalls / Intuitive Surgical, Inc. / Z-0275-2022

Z-0275-2022 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
December 1, 2021
Initiation Date
September 21, 2021
Termination Date
January 25, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,740 drapes (87 bobes)

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.

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