Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Softwa
Summary
The FDA issued a Class II for Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US by CMR SURGICAL LIMITED. Reason: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk..
Details
Source
Device Recall
External ID
Z-2717-2026
Action Date
2026-07-15
Status
Ongoing
Category
device
Product Description
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.
Lot/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.
Quantity Affected: 2
Reason for Recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Distribution
US Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-09
Company
Cambridge, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.
CMR SURGICAL LIMITED has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CMR SURGICAL LIMITED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CMR SURGICAL LIMITED have FDA actions?
CMR SURGICAL LIMITED has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2717-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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