Cmr Surgical Limited: Modular Electromechanical Surgical System
Recall Summary CMR Surgical Limited is recalling the Versius Surgical System (model V-SS-1020, software version Pratchett 1 version 62.1) used in minimally invasive surgery. The system was manufactured without Secure Boot enabled, creating a potential cybersecurity vulnerability. The recall affects units distributed nationwide across the United States.
- Recalling firm
- CMR SURGICAL LIMITED
- Product
- 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.
- Reason
- Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of California.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1efa1063-d934-41aa-837b-988d914dff08