GE ApexPro v6.0 software may lose ECG and SpO2 monitoring
GE HealthCare ApexPro v6.0 eDelivery Software is being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
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: FDA Class II recall where patient ECG and SpO2 monitoring may be lost, a risk of harm with no injuries reported in the source.
Plain-English summary
GE HealthCare ApexPro v6.0 eDelivery Software, REF 5700026, used with the ApexPro CARESCAPE Telemetry Server (CTS) v6.0, is being recalled. The action covers 2,187 units.
GE HealthCare has become aware of a situation, which it describes as unlikely, where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server 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. The FDA classified the action as Class II.
Distribution was worldwide. The software runs in hospital monitoring networks rather than being sold to consumers.
Facilities should identify affected installations using the REF number, UDI and serial or sales order numbers in the recall notice and follow the instructions issued by GE HealthCare.
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
- ecg
- spo2
- network-failure
- class-ii
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.
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