ROSA® Brain 3.0.1Recalls & reported problems
Medtech · Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B Power cord US hospital grade plug Straight 5M · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760244031754), received between Dec 19, 2019 and Dec 19, 2019 — classified as 1 malfunction.
1 FDA recall record name this device's 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, 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
- 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-1150-2020 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2019Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE, UPON VERIFYING OUR REGISTRATION, THE POINTER PROBE INADVERTENTLY CAUSED A SUPERFICIAL LACERATION. THE ROSA WAS EMERGENTLY DISCONNECTED. THE SURGEON FEELS THERE IS NO RELATIONSHIP OF THE OCCURRENCE TO A PREVIOUSLY RELEASED RECALL.
Patient problems: Laceration(s)
MAUDE report 9494826 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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