Z-0275-2022 Class II Terminated
FDA device recall Z-0275-2022 was initiated by Intuitive Surgical, Inc. on September 21, 2021 and is designated Class II. Reason for recall: Incorrect expiration date on its package labeling (shipper box and inner carton label). The recall status is terminated (terminated January 25, 2024). Affected quantity: 1,740 drapes (87 bobes).
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.