FDA Device recall Z-0725-2020
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healt…
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healt… by Ge Healthcare, citing when connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Cen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0725-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-12 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
ApexPro Telemetry System - Product Usage: The 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.
Reason
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.
Identifiers
| code_info | Serial Numbers: Mfg. Lot or Serial # UDI # SEE09020009GA 00840682109260SEE09020009GA SEE09020010GA 00840682109260SEE…Serial Numbers: Mfg. Lot or Serial # UDI # SEE09020009GA 00840682109260SEE09020009GA SEE09020010GA 00840682109260SEE09020010GA SEE09020011GA 00840682109260SEE09020011GA SEE09020012GA 00840682109260SEE09020012GA SEE09020013GA 00840682109260SEE09020013GA SEE09020015GA 00840682109260SEE09020015GA SEE09020017GA 00840682109260SEE09020017GA SEE09020020GA 00840682109260SEE09020020GA SEE09020022GA 00840682109260SEE09020022GA SEE09020023GA 00840682109260SEE09020023GA SEE09020024GA 00840682109260SEE09020024GA SEE09020027GA 00840682109260SEE09020027GA SEE09020028GA 00840682109260SEE09020028GA SEE09020029GA 00840682109260SEE09020029GA SEE09020030GA 00840682109260SEE09020030GA SEE09020031GA 00840682109260SEE09020031GA SEE09020032GA 00840682109260SEE09020032GA SEE09020033GA 00840682109260SEE09020033GA SEE09020034GA 00840682109260SEE09020034GA SEE09020035GA 00840682109260SEE09020035GA SEE09020036GA 00840682109260SEE09020036GA SEE09020038GA 00840682109260SEE09020038GA SEE090200 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0725-2020%22
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