Class II U.S. Food and Drug Administration

Cmr Surgical Limited Brand Name: Versius Surgical System US Product Name: Vesius recall: Secure Boot was mistakenly not enabled at manufacturing time

Recall published 3 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2717-2026
Published
July 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cmr Surgical Limited
Product type
Medical devices
Units affected
2
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
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.
UPC codes
05060548211226

Products covered by this recall

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05060548211226

Model or item number

On the rating label, the box or the instruction sheet.

  • V-SS-1020 Software Version
  • 66496 Software Revi

Serial number

On the rating plate, often next to the date of manufacture.

  • 66495

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Cmr Surgical Limited — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: CMR SURGICAL LIMITED — 1 Evolution Business Park, Cambridge

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cmr Surgical Limited medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05060548211226; model number V-SS-1020 Software Version, 66496 Software Revi. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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