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

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

Tags

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

Related exam domains

CISSP 3: Security Architecture and Engineering; CISM 3: Information Security Program

Source record id

Z-1355-2026

First seen by InfoSec Signals

Sep 23, 2026

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

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