CARESCAPE Central Station V2 Integrated MAI 700Recalls & reported problems

Ge Medical Systems Information Technologies, Inc. · CARESCAPE CENTRAL STATION V2 MAI 700 ATO MODEL · Class 2

All models of CARESCAPE Central Station (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 2 still open.

3 other recalls cover devices cleared under the same FDA submission (K162012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

May 10, 2022Class IIOpen, Classified
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
Z-1265-2022 · Root cause: Process control · Recall details · FDA record ↗
Jan 28, 2022Class IIOpen, Classified
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Z-0808-2022 · Root cause: Software design · Recall details · FDA record ↗
Jan 11, 2018Class IITerminated
CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
Z-0487-2018 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162012. One submission often covers many models, so check the product and lot details in each record.

Z-3143-2026 · Jul 30, 2026 · Open, Classified
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Z-0213-2026 · Sep 5, 2025 · Open, Classified
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
Z-0214-2026 · Sep 5, 2025 · Open, Classified
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube

Device details

UDI-DI	`00840682109666`
Brand	CARESCAPE Central Station
Model	V2 Integrated MAI 700
Company	Ge Medical Systems Information Technologies, Inc.
Product code	DSI · DETECTOR AND ALARM, ARRHYTHMIA
Class	Class 2
FDA submission	K162012
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Apr 22, 2025

Device type (GMDN): Centralized patient monitor

A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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