Recall Z-0275-2022 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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 s
| Date | Sep 21, 2021 |
| Status | Terminated |
| Reason | Incorrect expiration date on its package labeling (shipper box and inner carton label). |
| Root cause | Labeling Change Control |
| Action | On September 21, "Urgent Medical Device Recall"-customer letter was sent out to the affected sites, via FedEx and an updated letter with legible print of labels on October 21 to non-responder customers for incorrect expiration date on the package labeling (shipper box and inner carton) label. Both shipper and carton label had expiration date as 11/30/2023 instead of 01/31/2023. The Affected product is being requested to be returned per attached field safety notice (5556010-01 Rev A). The customers had been requested to fax or E-mail the acknowledgement form to, Attn: REGULATORY COMPLIANCE FIE |
| Quantity | 1,740 drapes (87 bobes) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |