Versius Surgical System Console affected by cybersecurity vulnerability
CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or actual cybersecurity breaches documented in the source. The hazard is theoretical—a potential vulnerability—and the device is a surgical system used in controlled hospital environments. Moderate severity applies for a Class II precautionary recall with no realized harm.
Plain-English summary
CMR Surgical Limited is recalling the Versius Surgical System US, specifically the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1), distributed nationwide in California. The device is a modular, open console, software-controlled electromechanical system designed for surgeons to perform minimally invasive surgery.
The recall was initiated because Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. The affected units have serial numbers 66495 and 66496, and carry UDI-DI 05060548211226. No expiry date applies to this device.
Facilities using the affected Versius Surgeon Console units should contact CMR Surgical Limited for further guidance on remediation steps.
The recalled product
- 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…
- Manufacturer
- CMR SURGICAL LIMITED
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 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.
Distribution
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