ROBOT ROSA ONE (USA) 3.1.1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03760244032492), received between Jun 17, 2022 and Mar 13, 2026 — classified as 8 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K182417, K182848); 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 18, 2026.

Recalls naming this device

1. Jan 6, 2020Class IITerminated

   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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY, A ROBOTIC ARM LOCKED UP AND DID NOT MOVE SMOOTHLY. THE ISSUE OCCURRED INTRA-OPERATIVELY WHILE THE SYSTEM WAS IN USE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597695 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21841923 ↗
• InjuryJan 23, 2025Failure to Calibrate; Unintended Movement; Failure to Calibrate; Unintended Movement

  IT WAS REPORTED DURING SURGERY; THE ROBOT WAS ABLE TO CALIBRATE THE EMPTY ARM BUT FAILED TO CALIBRATE THE POINTER PROBE. RECALIBRATION EMPTY WAS PERFORMED SUCCESSFULLY AND THEN POINTER PROBE CALIBRATED SUCCESSFULLY. ARM WAS THEN DRIVEN TOWARDS FIDUCIALS. ARM BEGAN TO DRIFT IN FAST MODE WITH NO MANUAL INPUT. FULL POWER DOWN WAS PERFORMED AND ISSUED PERSISTS. PROCEDURE WAS ABORTED AFTER IMPLANTATION OF BONE FIDUCIALS THAT WOULD REQUIRE CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223802 ↗
• MalfunctionJan 7, 2025Incorrect Measurement; Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091419 ↗
• MalfunctionDec 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, FOLLOWING ELECTRODE IMPLANTATION, AN O-ARM SCAN WAS TAKEN TO CONFIRM ELECTRODE LOCATION. ALL THE ELECTRODES APPEARED INACCURATE BY A FEW MILLIMETERS, WITH TWO BEING SUBDURAL. THE TWO SUBDURAL ELECTRODES WERE REMOVED AND REPLACED ONCE THE DURA WAS REOPENED. AFTER LOOKING CLOSER AT THE MERGE, IT APPEARED SLIGHTLY OFF. THE MERGE WAS REDONE MULTIPLE TIMES WITH THE PRE-OP CT ¿CTBONEFIDUCIAL¿ AND MR ¿PRE-IMPLANTATION TIMPRAGE¿ BUT WAS STILL OFF, AND WAS ULTIMATELY ADJUSTED MANUALLY, WHICH RESULTED IN THE ELECTRODES APPEARING MORE ACCURATE. IN ADDITION, A TRAJECTORY WAS MADE AT ONE OF THE BONE FIDUCIALS TO CONFIRM THE PATIENT HADN¿T SHIFTED AND THE ROBOT REMAINED ACCURATE AND THE TRAJECTORY TO THE FIDUCIAL WAS SPOT ON. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047235 ↗
• InjuryOct 25, 2024Connection Problem; Connection Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533044 ↗
• InjurySep 30, 2024Failure to Calibrate; Unintended Movement; Failure to Calibrate; Unintended Movement

  IT WAS REPORTED THAT APPROXIMATELY A MONTH AGO A PATIENT WAS PUT UNDER ANESTHESIA AND HAD BONE FIDUCIALS PUT IN WHEN THE CASE HAD TO BE ABORTED DUE TO A DRIFTING ARM AND BEING UNABLE TO CALIBRATE THE TOOLS. THE SURGERY WAS COMPLETED TWO DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333627 ↗
• InjuryJul 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19706458 ↗
• MalfunctionMay 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381281 ↗
• MalfunctionAug 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486716 ↗
• MalfunctionAug 2, 2023Connection Problem; Connection Problem

  IT WAS REPORTED DURING CORRECTIVE MAINTENANCE, CONTROLLER WILL NOT CONNECT TO COMPUTER. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445794 ↗
• MalfunctionMay 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939184 ↗
• MalfunctionApr 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751083 ↗
• MalfunctionMar 31, 2023Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655253 ↗
• MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER A SEEG CASE, IT WAS NOTICED ALL OF THE ELECTRODE PLACEMENTS WERE OFF A FAIR AMOUNT. ADDITIONALLY, THERE WERE SOME REGISTRATION ERRORS DURING THE CASE DUE TO THE FACT THAT ONE OF THE FIDUCIALS WAS RIGHT ON TOP OF A TRAJECTORY, THIS LEAD TO THEM DECIDING TO UTILIZE ONLY 4 OUT OF 5 BONE FIDUCIALS FOR REGISTRATION. THE FIRST BONE FIDUCIAL REGISTRATION THEY DID GOT AN RMS OF 1.00 AS THEY DID 4 OUT OF 5 OF THE FIDUCIALS AND THEN VALIDATED. THE SECOND TIME THEY DID REGISTRATION THEY DELETED THE FIFTH BONE FIDUCIAL COMPLETELY SO REGISTRATION UTILIZED ONLY 4 OUT 4 OF THE BONE FIDUCIALS. IT WAS NOTICED THAT THESE TRAJECTORIES WERE STILL OFF BY A GOOD AMOUNT POST-SURGERY. IT WAS NOTICED THAT ONE OF THE FIDUCIALS HAD SHIFTED AFTER LOOKING AT THE SCAN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584229 ↗
• InjuryMar 13, 2023Disconnection; Disconnection

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16532881 ↗
• MalfunctionMar 13, 2023Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SOFTWARE THAT WAS USED WITH THIS DEVICE IS A COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16532831 ↗
• MalfunctionMar 13, 2023Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SOFTWARE THAT WAS USED WITH THIS DEVICE IS A COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16532776 ↗
• MalfunctionMar 13, 2023Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SOFTWARE THAT WAS USED WITH THIS DEVICE IS A COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16532764 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15315047 ↗
• MalfunctionJul 26, 2022Positioning Problem; Positioning Problem

  AFTER THE SOFTWARE UPGRADE OF THE ROBOT, THE ARM MOVED IN FROM THE OPPOSITE DIRECTION DURING THE APPLICATIVE TEST. INSTEAD OF MOVING FROM THE TOP TO THE LEFT IT CAME IN FROM THE BOTTOM RIGHT. ON THE FOUR TRAJECTORY THE ARM LOCKED ITSELF OUT AND THE EMERGENCY STOP CAME ON. THE ROBOT WAS TURNED OFF AND THE EMERGENCY BUTTON WAS UNPLUGGED AND RE PLUGGED IN. THE ROBOT STARTED WORKING AS NORMAL AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102392 ↗
• InjuryJun 17, 2022Malposition of Device; Malposition of Device

  DURING THE DBS PROCEDURE MULTIPLE O-ARM SPINS WERE MERGED TO THE FIRST BONE FIDUCIAL O-ARM SPIN. ONLY THE LAST O-ARM SPIN PRESENTED A MERGE ISSUE. THE LATEST CT SCAN WAS ROTATED 90 DEGREES OVERLAYING THE FIDUCIAL O-ARM SPIN. ADJUSTMENTS WERE MADE USING THE ROTATION AND TRANSLATION TOOLS, HOWEVER AFTER RECALCULATING, THE SYSTEM IMMEDIATELY REVERTED TO THE ORIGINAL 90 DEGREE MIS-ORIENTATION. SINCE THE SCANS WERE NOT MERGING CORRECTLY AFTER RECALCULATING, IT WAS ATTEMPTED MERGING THE LAST O-ARM CST TO THE ORIGINAL PLANNING MRI. THIS MERGE PRESENTED NO ISSUES AND AFTER CAREFUL OBSERVATION THE SURGEON ACCEPTED THE MERGE ON THE SOFTWARE. THESE LAST O-ARM SPINS DURING THE OPERATION CONFIRMED ACCURATE ELECTRODE PLACEMENT. HOWEVER, 2 WEEKS POST-OPERATION SURGEON CONTACTED ZIMMER BIOMET CLAIMING THE CT SCANS OBTAINED AFTER PROCEDURE AND O-ARMS DURING PROCEDURES DO NOT MATCH RESULTING IN INACCURATE ELECTRODE PLACEMENT. CUSTOMER IS REQUESTING AN INVESTIGATION TO DETERMINE IF THE MERGING SOFTWARE CONTRIBUTED TO INACCURATE ELECTRODE PLACEMENT. PATIENT IMPACT IS UNKNOWN HOWEVER SURGEON INDICATED A REVISION SURGERY MAY BE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182417, K182848. 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 sta
• Z-1150-2020 · Jan 6, 2020 · Terminated
  ROSA Brain 3.0 Application-Brain