CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report
Versius Surgical System US Vesius Surgeon Console US recalled
CMR Surgical is recalling Versius Surgical System US Vesius Surgeon Console US, distributed nationwide in the US. The recall was initiated on 9 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2717-2026
- FDA event ID
- 99280
- Recalling firm
- CMR Surgical, Cambridge, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jun 2026
- FDA classified
- 9 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 9 Jun 2026 | Recall initiated by company | |
| 9 Jul 2026 | Classified by FDA | +30 days |
| 15 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Why was it recalled?
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the state of California.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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