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Carescape Central Station MAI800

by Ge Medical Systems Information Technologies, Inc. United States EUDAMEDGUDID

Ref 5867474-03Model Version 3 Product code DQKEMDN Z1203020292

Regulatory status

as of 26 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00160H3 Basic UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278343383 UDI-DIDate11 Feb 2026ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

6 recalls · 5 ongoing · FDA

    • Ongoing Z-3143-2026 FDA Class II initiated 30 Jul 2026

    Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

  • 2 recalls, same reason

    • Ongoing Z-0213-2026 FDA Class II initiated 5 Sep 2025
    • Ongoing Z-0214-2026 FDA Class II initiated 5 Sep 2025

    Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

    • Ongoing Z-1265-2022 FDA Class II initiated 10 May 2022

    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.

    • Ongoing Z-0808-2022 FDA Class II initiated 28 Jan 2022

    If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

    • Terminated Z-0487-2018 FDA Class II initiated 11 Jan 2018

    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.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Carescape Central Station
Generic Name
Centralized patient monitor
Device Name
CARESCAPE Central Station Software Version 3
Model / Ref / Catalog
Version 3, 5867474-03, MAI800
Primary DI / UDI-DI
00195278343383
Basic UDI-DI
8406821BUG00160H3
Direct Marketing DI
00195278343383
510(k) Number
FDA Product Code
DQK, DSI, DXJ
EMDN Code
Z1203020292 Multi-parameter monitors - medical device software
GMDN Term
Centralized patient monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1425, 870.1025, 870.2450
Market of Registration
France
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Version 3
5867474-03
GUDID
MAI800
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K162012)

Other devices from Ge Medical Systems Information Technologies, Inc.

See all devices from Ge Medical Systems Information Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • FDA UDI f0168c1e-6126-46d8-99a8-997e89920dab 35 fields · synced 24 Oct 2026
  • EUDAMED 00195278343383|8406821BUG00160H3 61 fields · synced 24 Oct 2026