FDA-Device2026-06-03Class IIPROCESSING DEFECT

GE HealthCare ApexPro CARESCAPE Telemetry Server recalled for potential loss of patient ECG and SpO2 monitoring

OTHERNationwide distribution

GE ApexPro CARESCAPE Telemetry Server recalled for monitoring loss risk

GE HealthCare has identified a situation where the ApexPro CARESCAPE Telemetry Server (versions 5.0 and 6.0) can lose ECG and SpO2 monitoring data if the system loses network connection to the central monitoring station. This affects 14 units used in hospitals and clinical settings.

  • If you operate this system, contact GE HealthCare Service immediately to discuss the issue and available solutions.
  • Ensure backup manual monitoring procedures are in place until your system is reviewed.
  • Do not rely solely on this system for patient monitoring until confirmed safe by GE Service.
Hazard

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Sold states
Worldwide distribution.
Affected count
14 units
Manufactured in
3114 N Grandview Blvd, Waukesha, WI, United States
Products
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2026

Also reported as

More GE Medical Systems Information Technologies Inc recalls

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