FDA recall Z-2260-2020

Intuitive Surgical, Inc. · Class II · device

Product

da Vinci SP surgical system

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-04-01
Report date: 2020-06-10
Termination date: 2021-12-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2260-2020