ROBOT ROSA ONE (USA)Recalls & reported problems across all models
Medtech · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 3 models of ROBOT ROSA ONE (USA) by Medtech in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2021 and Mar 13, 2026 — classified as 10 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ROBOT ROSA ONE (USA) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 ROBOT ROSA ONE (USA) problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings11
- Positioning Problem5
- Activation, Positioning or Separation Problem4
- Unintended Movement3
- Adverse Event Without Identified Device or Use Problem2
- Connection Problem2
- Failure to Calibrate2
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Intracranial Hemorrhage4
- Hematoma2
- Paralysis1
ROBOT ROSA ONE (USA) models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROBOT ROSA ONE (USA) 3.1.1.0Orthopedic Stereotaxic Instrument1 recall22 reports
- ROBOT ROSA ONE (USA) 3.1.4.0Orthopedic Stereotaxic Instrument4 reports
- ROBOT ROSA ONE (USA) 3.1.5Orthopedic Stereotaxic Instrument1 report
Recent ROBOT ROSA ONE (USA) adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionFeb 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED POST-OPERATIVELY THERE WAS A MERGE ISSUE. AFTER VERIFYING MERGE OF OAM SCAN, ENTRY POINTS LOOKED WRONG, BUT WHEN REMERGING THE SCAN TO THE PREVIOUS ORAM SPIN, IT WAS ABLE TO RIGHT THE MERGE. THE ORIGINAL MERGE LOOKED NORMAL, BUT SEEMS IT WAS OFF. INVESTIGATION RESULTS CONFIRMED ENTRY POINT INACCURACY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21293634 ↗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 16, 2023Output Problem; Output Problem
IT WAS REPORTED DURING AN RNS IMPLANTATION SURGERY, AFTER PLACEMENT OF BOTH LEADS (TRAJECTORIES ¿R AMYGDALA¿ AND ¿R HIPPOCAMPUS¿) AN O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE ¿R HIPPOCAMPUS¿ LEAD WAS SUPERIOR TO THE PLANNED TRAJECTORY BY ABOUT 5 MM. THE ¿R AMYGLADA¿ LEAD WAS MINIMALLY SUPERIOR AND ANTERIOR TO THE PLANNED TRAJECTORY, BUT WAS DETERMINED TO BE SATISFACTORY. A NEW TRAJECTORY WAS PLANNED TO REPLACE ¿R HIPPOCAMPUS¿. THIS NEW TRAJECTORY (¿TRAJECTORY 1¿) WAS PLANNED INFERIOR TO THE ¿R HIPPOCAMPUS¿ TRAJECTORY. THE LEAD WAS REMOVED AND RE-PLACED AT ¿TRAJECTORY 1¿. ANOTHER O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE LEAD WAS ALSO ABOUT 5 MM SUPERIOR TO ¿TRAJECTORY 1¿ AND ABOUT 3 MM SUPERIOR TO ¿R HIPPOCAMPUS.¿ THE SURGEON DETERMINED THAT THE LEAD PLACEMENT WAS SUFFICIENT AND DID NOT NEED FURTHER IMPROVEMENT. SURGEON ALSO NOTED THAT IT WAS POSSIBLE THE HEAD HAD MOVED IN THE CLAMP, AS THERE WAS SOME SLIGHT MOVEMENT TO THE HEAD FIXATION. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE AND THIS RESULTED IN A 30 MINUTE DELAY TO THE CASE. 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 17555520 ↗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 26, 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 17011520 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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