FDA recall, , Moderate risk
Versius Surgical System
The Versius Surgical System has a cybersecurity risk because Secure Boot was not enabled.
Summary by Recall Canary from the FDA notice
What happened
CMR SURGICAL LIMITED, located in Cambridge, United Kingdom, began a recall of the Versius Surgical System US and Vesius Surgeon Console US on June 9, 2026, because Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. The FDA added the recall to its Enforcement Report on July 9, 2026, and classified it the same day.
The product is described as a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery, with model V-SS-1020 and software version Pratchett 1 version 62.1. Distribution was in California.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
Versius Surgical System
- Model number
- V-SS-1020
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of California.
- Company
- CMR SURGICAL LIMITEDCambridge, United Kingdom
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99280
- Recall number
- Z-2717-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
