Intuitive Surgical recalls Patient Side Carts (REF: 380620/380652) used with da Vinci X/Xi systems due to potential instrument arm failure causing tissue injury. Affected units include specific serial numbers.
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
Intuitive Surgical is recalling Patient Side Carts with instrument arms used in da Vinci X and Xi surgical systems. These carts may have instrument arms that could fail, causing uncontrolled movement and tissue injury during surgery.
The instrument arms in these Patient Side Carts may experience insertion ballscrew failure, causing uncontrolled movement along the surgical insertion axis. This uncontrolled movement could lead to tissue injury during surgery.
Surgeons and surgical teams using the da Vinci X or Xi robotic surgical systems with the recalled Patient Side Carts are most at risk. The specific units affected include those with the listed serial numbers.
Check if your Patient Side Cart has the reference numbers 380620 (for da Vinci X) or 380652 (for da Vinci Xi). Affected units include specific serial numbers listed in the recall notice.
Look for the serial numbers listed in the recall notice: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093; IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962
The instrument arms may experience insertion ballscrew failure, causing uncontrolled movement along the surgical insertion axis, which could lead to tissue injury during surgery.
The recalled Patient Side Carts are used with the da Vinci X Surgical System (reference 380620) and da Vinci Xi Surgical System (reference 380652).
Check if your cart has the reference numbers 380620 (da Vinci X) or 380652 (da Vinci Xi) and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1262-2023 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1262-2023 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
