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Ongoing FDAEvent 98938 (4 months ago)

GE HealthCare Carescape Telemetry Server

GE HealthCare CARESCAPE Telemetry Server can have a persistent NO COMM or OFF NETWORK condition, potentially causing loss of ECG and SpO2 monitoring.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

GE Medical Systems Information Technologies Inc of Waukesha, Wisconsin began a recall on April 24, 2026, for multiple GE HealthCare products used with ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, including CARESCAPE Telemetry Server Ark models, ApexPro v6.0 eDelivery Software, and related software and disaster recovery USB kits.

The recall is due to an unlikely situation where a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center can result in potential loss of ECG and SpO2 monitoring. The FDA added the recall to its Enforcement Report on May 28, 2026, with worldwide distribution.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

  1. Product details

    GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;
    used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0;
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

  2. GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro Carescape Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    UDI-DI
    • 00195278512390
  3. Product details

    GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA;
    used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0;
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

  4. Product details

    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)

    UDI-DI
    • 00840682144773
  5. Product details

    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)

  6. GE HealthCare IOU Assy ARK2250 Carescape Telemetry Server, REF #2108729-901, Product Code SS9; ApexPro Carescape Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Details

Company began the recall
Sold in

Worldwide distribution.

Event ID
98938
Recall numbers
Z-2242-2026 to Z-2247-2026
Company
GE Medical Systems Information Technologies IncWaukesha, Wisconsin
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from GE Medical Systems Information Technologies Inc

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration