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RobotRisk / CMR Surgical / 2026-06-09

Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control

S2 · 06/09
2026 · CMR Surgical

Record

CompanyCMR Surgical
Categorymedical robotics
Typerecall
Date06/09
2026
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS2 (minor injury or single-unit damage)
Scale2 units distributed in the US (California)
Confidencehigh
VerificationCited source on file; not independently re-verified
SourceFDA

What happened

CMR Surgical recalled Versius Surgical System surgeon consoles (model V-SS-1020) after determining Secure Boot was mistakenly not enabled at manufacturing time, creating a potential cybersecurity risk; the firm notified customers, committed to reconfiguring affected consoles, and instructed users to inspect systems and monitor tamper-evident labels for unauthorized access.

CMR Surgical record context

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Comparable recall events in medical robotics

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S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S52026-03-11Intuitive SurgicalClass I recall of da Vinci SureForm stapler reloads after patient death
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S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure
S32024-10-28Noah MedicalFDA Class II recall: Galaxy System (GAL-001).

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