CARESCAPE Monitor B850 CPU-C1Recalls & reported problems
GE Healthcare Finland Oy · Class 2
All models of CARESCAPE (3)
Data updated Oct 18, 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 00840682105118), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Power Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K131414); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Power Problem1
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.
MalfunctionApr 18, 2024Power Problem; Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POWER MANAGEMENT SYSTEM FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19140250 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131414. One submission often covers many models, so check the product and lot details in each record.
- Z-1606-2015 · May 4, 2015 · TerminatedGE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
- Z-2085-2014 · Jun 13, 2014 · TerminatedGE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
- Z-1175-2014 · Feb 28, 2014 · TerminatedGE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in
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- Neurofax EEG-1200ANihon Kohden Corporation · Non-normalizing quantitative electroencephalograph software2 deaths25 reports
- Neurofax EEG-1260ANihon Kohden Corporation · Non-normalizing quantitative electroencephalograph software4 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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