NeuroProbeRecalls & reported problems
Alpha Omega Engineering CO. Ltd. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290014954946), received between Nov 5, 2024 and Nov 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Mechanical Problem; Mechanical Problem
THE FACILITY REPORTER DESCRIBED THE EVENT AS FOLLOWS: "DESCRIBE THE EVENT OR PROBLEM: SUPPLY WAS TESTED BY SURGEON BEFORE USING IT ON PATIENT AND SUPPLY WAS FOUND TO BE "MANUFACTURED INCORRECTLY." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CRANIOTOMY, DEEP BRAIN STIMULATOR WITH MICROELECTRODE RECORDING, FIRST ARRAY. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703590 ↗MalfunctionNov 5, 2024
SUPPLY WAS TESTED BY SURGEON BEFORE USING IT ON PATIENT AND SUPPLY WAS FOUND TO BE "MANUFACTURED INCORRECTLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609491 ↗
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- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.