CARESCAPE Central Station — Class II medical device recall Z-0727-2020
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-0727-2020 |
|---|---|
| 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 | 10,661 units |
| Serial numbers | SGJ14180008GP, SGJ14180009GP, SGJ14220011GA, SGJ14220014GA, SGJ14220015GA, SGJ14220016GA, SGJ14220017GA, SGJ14220019GA, SGJ14220023GA, SGJ14220024GA, SGJ14220026GA, SGJ14220027GA, SGJ14220029GA, SGJ14220032GA, SGJ14220033GA, SGJ14220034GA, SGJ14220037GA, SGJ14220038GA, SGJ14220041GA, SGJ14430047GA, SGJ14430048GA, SGJ14430051GA, SGJ14430052GA, SGJ14430055GA, SGJ14430057GA and 475 more |
Product
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
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-0727-2020. 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.