Facility

CMR SURGICAL LIMITED

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3015488559
Establishment type	Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	1 Evolution Business Park, Milton Road Cambridge Cambridgeshire, GB CB24 9NG
Registration status	Active · expires 2026
Parent company	CMR Surgical Limited (owner-operator 10094768)
Brand names	Versius Plus

Activity by year

Recalls (1)

Devices registered here (1)

Modular Electromechanical Surgical System
Product code SCV (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4964

Recalls & enforcement

Class IIOngoing2026-06-09
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

All facilities operated by CMR Surgical Limited

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CMR SURGICAL LIMITED (FEI 3015488559) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015488559-cmr-surgical-limited/

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