ApexPro Telemetry System — Class II medical device recall Z-0725-2020
Terminated recall by GE Healthcare, LLC, reported 2020-01-01. When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of th
| Recall number | Z-0725-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2026-03-02 |
| Quantity | 11,347 devices |
| UPC / GTIN / UDI-DI | 00840682109260 |
| Serial numbers | 00840682, 00840682109260, 00840682109260SEE08510008GA, 00840682109260SEE09020009GA, 00840682109260SEE09020010GA, 00840682109260SEE09020011GA, 00840682109260SEE09020012GA, 00840682109260SEE09020013GA, 00840682109260SEE09020014GA, 00840682109260SEE09020015GA, 00840682109260SEE09020016GA, 00840682109260SEE09020017GA, 00840682109260SEE09020018GA, 00840682109260SEE09020020GA, 00840682109260SEE09020022GA, 00840682109260SEE09020023GA, 00840682109260SEE09020024GA, 00840682109260SEE09020025GA, 00840682109260SEE09020027GA, 00840682109260SEE09020028GA, 00840682109260SEE09020029GA, 00840682109260SEE09020030GA, 00840682109260SEE09020031GA, 00840682109260SEE09020032GA, 00840682109260SEE09020033GA and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0725-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.