CARESCAPERecalls & reported problems across all models
GE Medical Systems Information Technologies, Inc. · 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
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of CARESCAPE by GE Medical Systems Information Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between May 8, 2024 and Jun 26, 2025 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
2 FDA recall records 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.
- Nov 12, 2019Class IITerminated
When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
Z-0725-2020 · Root cause: Software in the Use Environment · Recall details · FDA record ↗
- Aug 30, 2019Class IIOpen, Classified
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
Z-0175-2020 · Root cause: Software design · Recall details · FDA record ↗
Most reported CARESCAPE problems
Device problems
- Device Alarm System1
- Insufficient Device Problem Information1
- No Audible Alarm1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Tachycardia1
CARESCAPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARESCAPE Telemetry Server V4MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)2 recalls0 reports
- CARESCAPE Central Station v1ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)1 death2 reports
- CARESCAPE V100MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 report
Recent CARESCAPE adverse event reports
The 3 most recent reports across all models, 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 A PATIENT DEATH OCCURRED, ALLEGEDLY WITHOUT APPROPRIATE ALARMS PROVIDED BY THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 22338937 ↗MalfunctionJun 10, 2024
PATIENT WITH SUSTAINED VENTRICULAR TACHYCARDIA (VTACH) TO 160S FOR APPROXIMATELY 2 MINUTES. GE TELEMETRY READING MEDIUM LEVEL YELLOW ALARM AND READING RHYTHM AT TACHY. REGISTERED NURSE WAS AT BEDSIDE PROVIDING PATIENT CARE. RAPID RESPONSE CALLED WHEN VTACH EVENT BEGAN.
Patient problems: Tachycardia
MAUDE report 19497574 ↗MalfunctionMay 8, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THE CSCS V1 WAS NOT AUDIBLY ALARMING. THE VISUAL ALARMS WERE STILL PRESENT. THERE WAS NO RELATED ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269804 ↗
Other GE Medical Systems Information Technologies, Inc. products
All GE Medical Systems Information Technologies, Inc. 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.
How reports and recalls are matched · Editorial policy · Report an error on this page