Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

Tags

FDA recall, medical device, class 2, Gastroenterology, Urology, Process control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 7: Security Operations; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-1232-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.