Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software
FDA device recall Z-2717-2026 · posted 2026-07-09 · Open, Classified
Recall details
- Recalling firm
- CMR SURGICAL LIMITED
- Reason for recall
- Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
- Action taken
- On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles.
- Root cause
- Software design (manufacturing process)
- Status
- Open, Classified
- Product code
- SCV
- Quantity affected
- 2
- Distribution
- US Nationwide distribution in the state of California.
- Date initiated
- 2026-06-09
- Date posted
- 2026-07-09
- Location
- Cambridge, United Kingdom
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |