ROSA One 3.1.0.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760244030948), received between May 5, 2023 and Nov 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K182417); 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.

Recalls naming this device

1. Jan 6, 2020Terminated

   Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

   Z-1151-2020 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Incorrect Measurement; Incorrect Measurement

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658051 ↗
• MalfunctionMay 5, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SURGERY WHILE USING A ROSA, REGISTRATION AND VERIFICATION WERE SUCCESSFUL. AFTER THE FIRST DBS LEAD WAS PLACED, AN INTRAOPERATIVE IMAGE WAS TAKEN VIA O-ARM. AFTER MERGING THE IMAGES, THE LEAD WAS NOTED TO BE OVER 3MM OFF FROM THE TARGET. SURGEON REQUESTED TO CREATE A TRAJECTORY TO ONE OF THE BONE FIDUCIALS USED FOR REGISTRATION AFTER BEING CONCERNED THE HEAD HAD MOVED. WHEN DRIVING TO THE FIDUCIAL TRAJECTORY, IT WAS NOTICED THE TRAJECTORY WAS OFF FROM THE FIDUCIAL. SURGEON UNDRAPED AND REREGISTERED. REGISTRATION AND VERIFICATION WERE SUCCESSFUL. SURGEON USED TWO FIDUCIAL TRAJECTORIES TO CHECK THAT WE WERE ACCURATE. AFTER DRILLING THE SECOND BURR HOLE, THE SURGEON DROVE BACK TO ONE OF THE FIDUCIAL TRAJECTORIES TO CHECK WE HAD NOT MOVED. THE TRAJECTORY WAS OFF AGAIN. SURGEON HAD TO UNDRAPE AND REREGISTER A THIRD TIME. THE SECOND LEAD WAS PLACED AND INCISIONS WERE CLOSED. IT IS SUSPECTED THE RADIOLUCENT HEADFRAME ALLOWED THE HEAD TO MOVE. OVER 90 MINUTES WAS ADDED TO THE SURGERY DUE TO THE REREGISTRATION TIME. NO ADDITIONAL PATIENT IMPACT WAS REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182417. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2022 · Sep 22, 2021 · Open, Classified
  ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide s
• Z-1150-2020 · Jan 6, 2020 · Terminated
  ROSA Brain 3.0 Application-Brain