United StatesThe Versius Surgical System surgeon console (Model V‑SS‑1020, Software Pratchett 1 version 62.1; serial numbers 66495 and 66496; UDI‑DI 05060548211226) sold in California (2 units) is affected. It was recalled because Secure Boot was mistakenly not enabled at manufacturing, presenting a potential cybersecurity risk.
What's being recalled
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.
Recalling firm: CMR Surgical Limited, Cambridge, N/A, United Kingdom.
How to identify it
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.
The hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of California.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)