Brand Name: Versius Surgical System US recallZ-2717-2026 · Cmr Surgical Limited · initiated Jun 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cmr Surgical Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
FDA root cause category: Software design (manufacturing process)
What the company is doing
On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles. ***Update*** On July 8, 2026, the firm issued an updated letter which clarified the potential risk and instructions for the user. Users were instructed to keep the device in a secure environment with restricted access whether it was in clinical use or not. Users should inspect the system for signs of damage or interference before each use. Tamper-evident labels are located on the casework and will become damaged in the event of unauthorized access. Do not use the system if there is any damage or visible signs of interference on the tamper-evident labels and report immediately to CMR Surgical directly on [email protected] or via your local representative.
Recall details
- Recall number
- Z-2717-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 9, 2026
- Posted by the FDA
- Jul 9, 2026
- Recalling firm
- Cmr Surgical Limited
- Quantity
- 2
- Product code
- SCV
- FDA submissions
- K252111
- Distribution
- US Nationwide distribution in the state of California.
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Versius Surgeon Console V-SS-1020Cmr Surgical Limited · Modular Electromechanical Surgical System1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K252111 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Versius Camera Head (compatible with vLimeLite) 90911Cmr Surgical Limited · Modular Electromechanical Surgical System3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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