FDA Medical Device Recalls (openFDA)
CMR SURGICAL LIMITED: 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.
- Recall number
- Z-2717-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2026-06-09
- Posted
- 2026-07-09
- Terminated
- not on file
- Reason
- Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
- 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. ***Update*** On July 8, 2026, the firm issued an updated letter which clarified the potential risk and instructions for the user. Users were instructed to keep the device in a secure environment with restricted access whether it was in clinical use or not. Users should inspect the system for signs of damage or interference before each use. Tamper-evident labels are located on the casework and will become damaged in the event of unauthorized access. Do not use the system if there is any damage or visible signs of interference on the tamper-evident labels and report immediately to CMR Surgical directly on regulatory.external@cmrsurgical.com or via your local representative.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K252111"]
- PMA numbers
- not on file
- Product code
- SCV
- Firm FEI
- 3015488559
- Firm city
- Cambridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28