GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA;
Pending LLM rewrite. Source: FDA_DEVICE Z-2245-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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).
The recalled product
- Product
- GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; 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
- Category
- Medical Device — Devices
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)
- no UDI
- Serial Number or Sales Order Number: KSA7013962
- KSA5646256
- KSA5646267
- KSA5646268
- KSA5646321
- KSA5646328
- KSA5646242
- KSA5646251
- KSA5646257
- KSA5646284
- KSA5646289
- KSA5646295
- KSA5646297
- KSA5646306
- KSA5646314
- KSA6689326
- KSA6689333
- KSA6689378
- KSA7162600
Distribution
Distribution scope not specified by the agency.
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