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.
USBrand 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.
Recalling Firm: CMR SURGICAL LIMITED
Reason for Recall / Hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | N/A |
| Event id | 99280 |
| Address 1 | 1 Evolution Business Park |
| Address 2 | Milton Road; Cam |
| 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. |
| Postal code | N/A |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 2 |
| Reason for recall | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260609 |
| Initial firm notification | |
| Center classification date | 20260709 |
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Overview
- Recalling FirmCMR SURGICAL LIMITED
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of California.
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🚨 SAFETY ALERT: CMR SURGICAL LIMITED - 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 if your household is affected: https://therecallfile.com/recalls/brand-name-versius-surgical-system-us-product-name-vesius-surgeon-cons/FDA-Z-2717-2026
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