Reported Jan 1, 2020 · Terminated
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- ApexPro
- Telemetry System - Product UsageThe ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered
- Lot codes and dates
- Serial NumbersMfg. Lot or Serial # UDI #
1,515 of 1,515 codes
SEE09020009GA00840682109260SEE09020009GASEE09020010GA00840682109260SEE09020010GASEE09020011GA00840682109260SEE09020011GASEE09020012GA00840682109260SEE09020012GASEE09020013GA00840682109260SEE09020013GASEE09020015GA00840682109260SEE09020015GASEE09020017GA00840682109260SEE09020017GASEE09020020GA00840682109260SEE09020020GASEE09020022GA00840682109260SEE09020022GASEE09020023GA00840682109260SEE09020023GASEE09020024GA00840682109260SEE09020024GASEE09020027GA00840682109260SEE09020027GASEE09020028GA00840682109260SEE09020028GASEE09020029GA00840682109260SEE09020029GASEE09020030GA00840682109260SEE09020030GASEE09020031GA00840682109260SEE09020031GASEE09020032GA00840682109260SEE09020032GASEE09020033GA00840682109260SEE09020033GASEE09020034GA00840682109260SEE09020034GASEE09020035GA00840682109260SEE09020035GASEE09020036GA00840682109260SEE09020036GASEE09020038GA00840682109260SEE09020038GASEE09020040GA00840682109260SEE09020040GASEE09020042GA00840682109260SEE09020042GASEE09020043GA00840682109260SEE09020043GASEE09040045GA00840682109260SEE09040045GASEE09040046GA00840682109260SEE09040046GASEE09040047GA00840682109260SEE09040047GASEE09040048GA00840682109260SEE09040048GASEE09040050GA00840682109260SEE09040050GA
- Serial NumbersMfg. Lot or Serial # UDI #
- Amount recalled
- 11347 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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