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U.S. Department of Health and Human Services

Class 2 Device Recall Versius Surgical System US

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 Class 2 Device Recall Versius Surgical System USsee related information
Date Initiated by FirmJune 09, 2026
Date PostedJuly 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2717-2026
Recall Event ID 99280
510(K)NumberK252111 
Product Classification Modular electromechanical surgical system - Product Code SCV
ProductBrand 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 ContactGareth 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)
ActionOn 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 Commerce2
DistributionUS Nationwide distribution in the state of California.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = SCV
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