CMR SURGICAL LIMITED recalls Vesius Surgeon Console software version 62.1 (model V-SS-1020) due to potential cybersecurity risks from missing Secure Boot. Affected units may need updates to prevent unauthorized access.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
CMR SURGICAL LIMITED is recalling the Vesius Surgeon Console software version 62.1 (model V-SS-1020) because Secure Boot was not enabled during manufacturing, which could allow unauthorized access. This is a cybersecurity issue that affects medical devices used in surgery.
The Secure Boot feature was not enabled during manufacturing, which could allow unauthorized code execution on the device. This might lead to potential security vulnerabilities if the system is compromised, but it does not cause physical harm or immediate danger.
Surgeons and medical facilities using the Vesius Surgeon Console software version 62.1 (model V-SS-1020) are affected. The risk is low as this is a software issue that does not cause immediate harm but requires attention to prevent potential security breaches.
Check for the model number V-SS-1020 and software version 62.1 on the device. The serial numbers 66495 and 66496 are also associated with this specific recall.
Verify the software version on your Vesius Surgeon Console; if it is 62.1, it is affected.
Reach out to CMR SURGICAL LIMITED for guidance on securing the device or obtaining updates.
The recall addresses a potential cybersecurity risk, not immediate physical danger. The risk is low as it does not cause injury but requires attention to prevent unauthorized access.
Check for the model number V-SS-1020 and software version 62.1. Serial numbers 66495 and 66496 are also affected units.
No, the recall does not require immediate discontinuation. Affected devices can remain in use with proper security measures.
We’ve drafted a message you can send CMR SURGICAL LIMITED to request your refund or repair — edit it as you like.
Subject: Recall Z-2717-2026 — CMR SURGICAL LIMITED CMR SURGICAL LIMITED Hello, I own a CMR SURGICAL LIMITED that is covered by recall Z-2717-2026 from CMR SURGICAL LIMITED. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.