GE Medical Systems Information Technologies Inc: GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor,

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).

Details from the source

Reason for recall: 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). Distribution: Worldwide distribution. Quantity: 7 units Lot/code info: Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.