Versius Camera Head (compatible with vLimeLite) 90911Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060548210748), received between Aug 17, 2026 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K252111); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was alleged that the cable connector was found damaged during surgery setup. The exact cause of the damage could not be determined, as no specific event leading to the failure was identified. However, this type of connector damage is typically associated with excessive or misaligned force during connection or disconnection and is therefore considered most likely to be handling-related. As spare camera head was used and the procedure was successfully complete with the use of Versius Surgical System. The camera cable was subsequently replaced. No harm was reported in relation to this event. At the time of this report, no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896103 ↗
• MalfunctionAug 25, 2026Physical Resistance/Sticking

  Reporter alleged that during non-clinical use on (b)(6) 2026, the camera head experienced latch issues. CMR Surgical Ltd does not consider this report and content to be an admission that its product is defective or that it has caused a death or serious injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427507 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274491 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K252111. One submission often covers many models, so check the product and lot details in each record.

• Z-2717-2026 · Jun 9, 2026 · Open, Classified
  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 V