Dispos. Clip-On Remote Control 53151Recalls & reported problems
Brainlab SE · 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481005658), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K092467, K102990, K252562); 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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Parameter Calculation Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT DURING A THR SURGERY, WHEN REGISTERING THE LUNATE SURFACE OF THE ACETABULUM, THE COMPUTER IMMEDIATELY JUMPED FORWARD AND STARTED COLLECTING THE FOSSA. THE SURGEON WAS NOT CLICKING THE REMOTE AND THE POINT PROBE WAS STILL COLLECTING FOSSA POINTS IN FREE SPACE. IN ADDITION, WHEN TRIED TO RE-REGISTER THE FOSSA, AN ERROR MESSAGE WAS PROMPTED, STATING THAT THE PELVIS NEEDED TO BE RE-REGISTERED. AT THIS POINT ALL THE PREVIOUS REGISTRATION WAS DELETED AND SINCE THE NECK HAD ALREADY BEEN RESECTED, THE SURGEON RESORTED TO MANUAL INSTRUMENTATION AND THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836674 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092467, K102990, K252562. One submission often covers many models, so check the product and lot details in each record.
- Z-0056-2021 · Aug 31, 2020 · TerminatedUltrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
- Z-0959-2017 · Oct 27, 2016 · TerminatedFemoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
- Z-0598-2016 · Apr 22, 2013 · TerminatedBrainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag
Other Neurological Stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
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
- 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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