FDA Device recall Z-0727-2020
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within…
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within… 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-0727-2020 |
| 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
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
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: SGJ14180008GP SGJ14180009GP SGJ14220011GA SGJ14220014GA SGJ14220015GA SGJ14220016GA SGJ14220017G…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 SGJ14430060GA SGJ14430061GA SGJ14440067GA SGJ14440071GA SGJ14440073GA SGJ14440077GA SGJ14440078GA SGJ14440081GA SGJ14440082GA SGJ14440085GA SGJ14440086GA SGJ14450092GA SGJ14450094GA SGJ14450095GA SGJ14450096GA SGJ14450097GA SGJ14450098GA SGJ14450099GA SGJ14450101GA SGJ14450104GA SGJ14450105GA SGJ14450106GA SGJ14450107GA SGJ14450109GA SGJ14450141GA SGJ14450142GA SGJ14450145GA SGJ14450146GA SGJ14450147GA SGJ14450152GA SGJ14450155GA SGJ14450156GA SGJ14450159GA SGJ14450161GA SGJ14450162GA SGJ14450163GA SGJ14450164GA SGJ14450168GA SGJ14450170GA SGJ14450171GA SGJ14450 |
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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-0727-2020%22
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