CARESCAPE B450Recalls & reported problems across all models
GE Healthcare Finland Oy · 2 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 B450 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of CARESCAPE B450 by GE Healthcare Finland Oy in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 22, 2025 and Aug 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Data Problem” (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 B450 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 · names 2 of these models · Recall details · FDA record ↗
Most reported CARESCAPE B450 problems
Device problems
- Data Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
CARESCAPE B450 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARESCAPE B450 MBA313Thermometer, electronic, clinical1 recall1 report
- CARESCAPE B450 MBA323DETECTOR AND ALARM, ARRHYTHMIA1 recall0 reports
Recent CARESCAPE B450 adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Improper or Incorrect Procedure or Method; Data Problem; Improper or Incorrect Procedure or Method; Data Problem
IT WAS REPORTED THAT A PATIENT'S MONITORING DATA WAS INADVERTENTLY COMBINED WITH ANOTHER PATIENT. THE PATIENT WAS MISDIAGNOSED AND WAS UNNECESSARILY TREATED WITH MEDICATION. THE PATIENT DID NOT SUSTAIN ANY INJURY DUE TO THE UNNECESSARY TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22872117 ↗
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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