CARESCAPE Telemetry Server V4Recalls & reported problems

GE Medical Systems Information Technologies, Inc. · TELEMETRY SERVER V4 ATO MODEL · Class 2

All models of CARESCAPE (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K080251); 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 16, 2026.

Recalls naming this device

Nov 12, 2019Terminated
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, 2019Open, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080251. One submission often covers many models, so check the product and lot details in each record.

Z-2242-2026 · Apr 24, 2026 · Open, Classified
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiolo
Z-1522-2011 · Jan 28, 2011 · Terminated
GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed

Device details

UDI-DI	`00840682109260`
Brand	CARESCAPE
Model	Telemetry Server V4
Company	GE Medical Systems Information Technologies, Inc.
Product code	MHX · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Class	Class 2
FDA submission	K080251
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Feb 25, 2026

Device type (GMDN): General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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All MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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