Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons t
CMR SURGICAL LIMITED
The hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
UPC 05060548211226Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.