NA B125 Patient MonitorRecalls & reported problems
Ge Medical Systems Information Technologies, Inc. · B125 V1.5 PATIENT MONITOR ATO MODEL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682138581), received between Jun 26, 2025 and Jun 26, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Device Alarm System” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 26, 2025Device Alarm System; Insufficient Device Problem Information; Device Alarm System; Insufficient Device Problem Information
IT WAS REPORTED THAT THE MONITOR STILL DISPLAYED A "NORMAL" ECG AND SPO2 WHEN THE PATIENT WAS IN CARDIAC ARREST. THE PATIENT WAS CODED BUT DID NOT SURVIVE.
Patient problems: Insufficient Information
MAUDE report 22338911 ↗
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- Portrait VSM MVC101Ge Medical Systems Information Technologies, Inc. · Oximeter, ear1 recall0 reports
- TruSignal SpO2 TS-SE-3GE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
- MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor 1794Masimo Corporation · Oximeter, ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- TruSignal SpO2 TS-APGE Healthcare Finland Oy · Oximeter, ear1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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