GE HealthCare ApexPro Cardiac Monitor May Lose ECG and SpO2 Monitoring
GE HealthCare ApexPro v6.0 cardiac telemetry software may experience loss of cardiac and oxygen monitoring due to network disconnection at the central monitoring station. Approximately 2,187 units are affected worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a risk-of-harm product (cardiac telemetry monitoring system) where network connectivity loss could prevent critical patient monitoring. No patient injuries or illnesses have been reported to date, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE HealthCare ApexPro v6.0 eDelivery Software, used with ApexPro CARESCAPE Telemetry Server (CTS) v6.0, is subject to this FDA Class II recall. The software can experience a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center, which can result in potential loss of ECG and SpO2 monitoring.
Approximately 2,187 units are affected worldwide. The software is used in healthcare facilities for physiological patient monitoring with arrhythmia detection and alarms.
No patient injuries or illnesses have been reported at this time.
The recalled product
- Product
- 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)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- monitoring-loss
- connectivity-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI (01)00195278512390(10)APv6.0.0.5
- Serial Number or Sales Order Number: SUV25423440TA
- SUV25423443TA
- SUV25423444TA
- SUV25423445TA
- SUV25423446TA
- SUV25423447TA
- SUV25493641TA
- SUV26093921TA
- SUV26093922TA
- SUV26093923TA
- SUV26093924TA
- SUV26093925TA
- SUV26093926TA
- SUV26093927TA
- SUV26093928TA
- SUV26093929TA
- SUV26093930TA
- SUV26093931TA
- SUV26093932TA
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03