⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

CMR SURGICAL LIMITED: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchet

Medical DevicesSource: FDA (device) · Date: 2026-07-15

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of California.
Recall initiated
2026-06-09
Code info
UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.
Product quantity
2
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
N/A
Country
United Kingdom
Event id
99280
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.