Incident · Recall
CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability
CMR Surgical initiated a Class 2 recall (Z-2717-2026) of two Versius Surgeon Console units (Model V-SS-1020) because Secure Boot was mistakenly not enabled at manufacturing time, presenting a potential cybersecurity risk. The affected units were distributed in California; the firm began notifying customers on June 16, 2026, and will proactively configure Secure Boot on the affected consoles.
Occurred 2026-06-09 · CMR Surgical · Investigated by FDA
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Sources (1)
- FDA · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99280 · 2026-07-09
Status history
- Active · 2026-08-17 · agent:recon
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Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-17
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Unreviewed
Low confidence
Review state
Stable
Last reviewed 2026-08-17
Sources by quality tier
- 1
- primary-fda-database
- FDA database
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Canonical ID d09c1728-a510-4116-86b0-fe0f3a9dd642