{"recall":{"id":"fda-device-99280","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"CMR SURGICAL LIMITED recalls Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020","firm":"CMR SURGICAL LIMITED","date":"2026-06-09","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"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.","code":"UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.","quantity":"2","number":"Z-2717-2026","classification":"Class II"}],"reason":"Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of California.","nationwide":true,"states":[],"units":"2","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99280","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4d55778f059aff2a","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99280","record":[{"status":"Ongoing","city":"Cambridge","state":"N/A","country":"United Kingdom","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99280","recalling_firm":"CMR SURGICAL LIMITED","address_1":"1 Evolution Business Park","address_2":"Milton Road; Cam","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of California.","recall_number":"Z-2717-2026","product_description":"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.","product_quantity":"2","reason_for_recall":"Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.","recall_initiation_date":"20260609","center_classification_date":"20260709","report_date":"20260715","code_info":"UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device."}]}}