FDA-Device2026-06-03Class IIPROCESSING DEFECT

GE HealthCare CARESCAPE Telemetry Server v5 recalled for potential loss of ECG and SpO2 monitoring

OTHERNationwide distribution

GE HealthCare CARESCAPE Telemetry Server recalled for monitoring loss risk

GE HealthCare identified a rare condition in CARESCAPE Telemetry Server v5.0 and v6.0 where a persistent network communication failure at the central monitoring station can result in loss of ECG and SpO2 (heart rhythm and blood oxygen) monitoring. The problem occurs only when the system is in a "NO COMM" or "OFF NETWORK" state at the central station.

  • Check your facility's CARESCAPE Telemetry Server serial number against the list of affected units provided by GE HealthCare.
  • Contact GE HealthCare immediately if your system is affected.
  • Ensure backup cardiac monitoring procedures are in place for patients until the issue is resolved.
  • Do not ignore network communication alerts on the central monitoring station.
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
476 units
Manufactured in
3114 N Grandview Blvd, Waukesha, WI, United States
Products
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, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2242-2026

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