| Date Initiated by Firm | June 09, 2026 |
|---|
| Date Posted | July 09, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2717-2026 |
|---|
| Recall Event ID |
99280 |
| 510(K)Number | K252111 |
|---|
| Product Classification |
Modular electromechanical surgical system - Product Code SCV
|
| 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. |
|---|
| Code Information |
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.
|
| FEI Number |
3015488559
|
Recalling Firm/
Manufacturer |
CMR SURGICAL LIMITED
1 Evolution Business Park
Milton Road; Cam
Cambridge United Kingdom
|
| For Additional Information Contact | Gareth Hearn
414-3731413 |
|---|
Manufacturer Reason
for Recall | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 2 |
|---|
| Distribution | US Nationwide distribution in the state of California. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = SCV
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