Microstream 015715_RMS1Recalls & reported problems
Oridion Medical 1987 Ltd. · PM35PSP2 · 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 10884521551879), received between Oct 2, 2024 and Oct 10, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (2 reports).
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
- Temperature Problem2
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.
MalfunctionOct 10, 2024Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, MONITOR POWER CHARGING CORD COMBUSTED AND CAUGHT FIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421342 ↗MalfunctionOct 2, 2024Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE POWER CORD CAUGHT FIRE AND GOT BURNED AND MELTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350778 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.