GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER: recall status
Notice names this product. GE Medical Systems Information Technologies’s GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER is named in FDA Class II recall Z-2244-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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). Identifying details: Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA.. Units affected: 7 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER
Company / brand
GE Medical Systems Information Technologies
Lot / serial / date codes
Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA.
Distribution
Worldwide distribution.
Agency product description and boundaries
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)
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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…