FDAClass IIJuly 15, 2026

Brand Name: Versius Surgical System US Product Name recall

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version…

Why was Brand Name: Versius Surgical System US Product Name recalled?

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version…
Recalling firm
CMR SURGICAL LIMITED
Quantity
2
Distribution
US Nationwide distribution in the state of California.
Recall date
July 15, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls