Modular Electromechanical Surgical System
FDA adverse event reports and recall history for modular electromechanical surgical system (product code SCV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,360
- Deaths
- 0
- Injuries
- 29
- Malfunctions
- 1,331
Reports per year
Source: FDA adverse event reports by year received, 2025–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-09Open, ClassifiedSoftware design (manufacturing process)
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Monitor modular electromechanical surgical system automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.