GE CARESCAPE IOU assembly may lose ECG and SpO2 monitoring
GE HealthCare IOU assemblies for the ARK2250 CARESCAPE Telemetry Server are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of 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 IOU ASSY ARK2250 CARESCAPE Telemetry Server, REF 2108729-901, used with the ApexPro CARESCAPE Telemetry Server (CTS) v5.0, is being recalled. The action covers seven 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 assemblies are installed in hospital monitoring networks rather than sold to consumers.
Facilities should identify affected units using the REF number and serial or sales order numbers in the recall notice and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- 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)
- 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 (7)
- Serial #/Sales Order #: SS920500004SA
- SS920500005SA
- SS920500003SA
- SS920500006SA
- SS921120011SA
- SS921120019SA
- SS921120015SA.
Distribution
Distribution scope not specified by the agency.
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