FDAFDA recall Z-2717-2026 · Jul 15, 2026
CMR SURGICAL LIMITED: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catal recall
Recall found
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 system designed for surgeons to perform minimally invasive surgery.
Reason for recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the state of California.
- Recalling firm
- CMR SURGICAL LIMITED, Cambridge, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-09
Source: openFDA enforcement record Z-2717-2026 · search recall number Z-2717-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.