GE Medical Systems Information Technologies Inc: GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems Information Technologies Inc
- Product
- GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason / 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).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-04-24
- Code info
- UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.
- Product quantity
- 14 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 98938
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