Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2260-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

da Vinci SP surgical system

Product Classification:

Class II

Date Initiated: April 1, 2019

Date Posted: June 10, 2020

Recall Number: Z-2260-2020

Event ID: 85293

Reason for Recall:

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

Status: Terminated

Product Quantity: 17

Code Information:

Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030

Distribution Pattern:

U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea

Voluntary or Mandated:

Voluntary: Firm initiated