Z-2717-2026Class II

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number...

Name: Z-2717-2026 Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number...
Creator: Cmr Surgical Limited
Published: 2026-06-09
License: https://open.fda.gov/license/

CMR Surgical Inc. / initiated 2026-06-09 / Open, Classified / root cause: software

FDA source

CMR SURGICAL LIMITED began a recall of 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... on 2026-06-09. FDA classified it as Class II and gives the reason as "Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2717-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-09
Posted: 2026-07-09
Recalling firm: CMR Surgical Inc.
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.
Product code: SCV Modular Electromechanical Surgical System
Reason for recall: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2717-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2717-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09

Product code SCV

K252111Class IIVersius Surgical System (Versius Plus)Cmr Surgical Limited / cleared 2025-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)