CARESCAPERecalls & reported problems across all models
GE Healthcare Finland Oy · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one CARESCAPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of CARESCAPE by GE Healthcare Finland Oy in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2024 and Dec 19, 2025 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CARESCAPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 26, 2025Class IIOpen, Classified
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Z-0453-2026 · Root cause: Component change control · Recall details · FDA record ↗
Most reported CARESCAPE problems
Device problems
- Device Alarm System1
- No Audible Alarm1
- Power Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
CARESCAPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARESCAPE Monitor B450Thermometer, electronic, clinical1 recall0 reports
- CARESCAPE Monitor B850 CPU-C1Non-normalizing quantitative electroencephalograph software1 report
- CARESCAPE Monitor B650Oximeter1 death1 report
Recent CARESCAPE adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathDec 19, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
A PATIENT WAS BEING MONITORED WITH THE CARESCAPE B650 WHEN IT WAS REPORTED THAT THE PATIENT WAS FOUND IN ASYSTOLE, BUT THE DEVICE WAS NOT ALARMING AS EXPECTED. THE PATIENT DID NOT SURVIVE.
Patient problems: Insufficient Information
MAUDE report 23849803 ↗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 ↗
Other GE Healthcare Finland Oy products
All GE Healthcare Finland Oy devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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