The Recall Desk
HighFDA (Devices)·Z-1896-2020·Announced 2020-05-13

Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could affect surgical performance, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical Inc is recalling 270 Universal Surgical Manipulator (USM) units, also known as arms, used in the da Vinci Xi Surgical System (IS4000). These units are distributed worldwide, including in the United States and various international markets.

The recall is due to high friction points in the USM units, which can result in increased arm movement characterized by feelings of resistance, hesitation, and jerking. The USM units are part of the Patient Cart, which supports the instrument arms and camera arm used by surgeons to perform surgical tasks.

The affected units are installed on 100 unique systems. Specific serial numbers for the affected USM units are listed in the official recall documentation. Healthcare facilities and users should contact Intuitive Surgical for instructions on how to address the issue.

The recalled product

Product
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made 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 IS4000 system and its prim
Manufacturer
Intuitive Surgical Inc
Category
Medical Device — Surgical Robot
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736
  • SK0856
  • SK1318
  • SK1943
  • SK2228
  • SK2236
  • SK2239
  • SK2240
  • SK2242
  • SK2244
  • SK2248
  • SK2251
  • SK2255
  • SK2256
  • SK2259
  • SK2260
  • SK2261
  • SK2266
  • SK2269
  • SK2270

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical Inc

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Same hazard · mechanical failure

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