Versius Instrument Bedside Unit V-SS-2020

by Cmr Surgical Limited GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05060548211233 UDI-DI	Date9 Mar 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2717-2026 FDA Class II initiated 9 Jun 2026
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Specification

GUDID

Trade Name: Versius Instrument Bedside Unit
Generic Name: Robotic surgical telemanipulation system
Model / Reference: V-SS-2020

Primary DI / UDI-DI: 05060548211233
510(k) Number: K252111
FDA Product Code: SCV
GMDN Term: Robotic surgical telemanipulation system

Device Class: Class II
Regulation Number: 878.4964
GUDID distribution status: In Commercial Distribution

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See all devices from Cmr Surgical Limited →

Properties

Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Expiration Date: No